Boston Scientific CRMN11906 Implantable Defibrillator User Manual Part 2 Teligen Manual

Boston Scientific Corporation Implantable Defibrillator Part 2 Teligen Manual

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PACING THERAPIES

ATRIAL TACHY RESPONSE 5-19

Recovery Time

MSR

Paced rate

LRL

Rest Stage 1 RestStage 2

Time

Longer

Recovery Time

Nominal

Recovery Time

The ﬁgure shows the effect of higher and lower settings during a theoretical two-stage exercise test.

Figure 5-11. Recovery Time in exercise test

Programming Recovery Time for Normal Settings also changes the

corresponding selection for Post-Therapy Settings.

ATRIAL TACHY RESPONSE

ATR Mode Switch

ATR limits the amount of time that the ventricular paced rate is at the MTR

or exhibits upper-rate behavior (2:1 block or Wenckebach) in response to a

pathological atrial arrhythmia.

In the presence of detected atrial activity that exceeds the Atrial Arrhythmia

Rate Threshold, ATR switches the pacing mode from a tracking mode to a

nontracking mode as follows:

• From DDD(R) to DDI(R) or VDI(R)

• From VDD(R) to VDI(R)

An example of ATR behavior is shown (Figure 5-12 on page 5-20).

- DRAFT -

5-20 PACING THERAPIES

ATRIAL TACHY RESPONSE

ATR Counter

Duration Counter

0 8

Detect Duration Fallback Reset

0 8

Exit Count = 8

8 atrial cycles <

Atrial Arrhythmia

Rate Threshold

Entry Count = 8

8 atrial cycles >

Atrial Arrhythmia

Rate Threshold

Rate

Atrial

tachycardia

starts

Rate Smoothing

applied here

Atrial

tachycardia

confirmed

ATR Duration

fulfilled

Atrial

tachycardia

terminates

MODE SWITCHING

DDDR VDIR

DDDR

Atrial

tachycardia

termination

confirmed

Rate

Smoothing

applied

here

Atrial Arrhythmia

Rate Threshold =

170 min-1 (ppm)

MTR =

120 min-1 (ppm)

Atrial Rate

Right Ventricular

Rate

Sensor Rate

ATR/VTR Fallback

LRL = 70 min-1 (ppm)

LRL = 60 min-1 (ppm)

Figure 5-12. ATR behavior

NOTE: Parameter settings that reduce the atrial sensing window may inhibit

ATR therapy.

Atrial Arrhythmia Rate Threshold

The Atrial Arrhythmia Rate Threshold determines the rate at which the pulse

generator begins to detect atrial tachycardias.

The pulse generator monitors atrial events throughout the pacing cycle,

except during the atrial blanking period and the noise interrogation intervals.

Atrial events faster than the Atrial Arrhythmia Rate Threshold increase the

ATR detection counter; atrial events slower than the Atrial Arrhythmia Rate

Threshold decrease the counter.

When the ATR detection counter reaches the programmed entry count, the

ATR Duration begins. When the ATR detection counter counts down from the

programmed Exit Count value to zero at any point in time, ATR Duration and/or

fallback are terminated, and the ATR algorithm is reset. An event marker is

generated whenever the ATR detection counter is incremented or decremented.

NOTE: During post-therapy pacing, ATR functions the same as in normal

pacing.

- DRAFT -

PACING THERAPIES

ATRIAL TACHY RESPONSE 5-21

ATR Duration

ATR Duration determines the number of cardiac cycles during which the

atrial events continue to be evaluated after initial detection. This feature is

intended to avoid mode switching due to short, nonsustained episodes of atrial

tachycardia. If the ATR counter reaches zero during ATR Duration, the ATR

algorithm will be reset, and no mode switch will occur.

If the atrial tachycardia persists for the programmed ATR Duration, then

mode switching occurs and the ventricular rate begins decreasing to the

sensor-indicated rate, VRR rate or the ATR/VTR Fallback LRL, depending

on the programmed Fallback Mode.

Entry Count

The Entry Count determines how quickly an atrial arrhythmia is initially detected.

The lower the programmable value, the fewer the fast atrial events required to

fulﬁll initial detection. Once the number of fast atrial events detected equals

the programmable Entry Count, ATR Duration begins, and the Exit Count is

enabled.

CAUTION: Exercise care when programming the Entry Count to low values

in conjunction with a short ATR Duration. This combination allows mode

switching with very few fast atrial beats. For example, if the Entry Count was

programmed to 2 and the ATR Duration to 0, ATR mode switching could occur

on 2 fast atrial intervals. In these instances, a short series of premature atrial

events could cause the device to mode switch.

Exit Count

The Exit Count determines how quickly the ATR algorithm is terminated once

the atrial arrhythmia is no longer detected.

The lower the programmed value, the more quickly the pulse generator will

return to an atrial tracking mode. Once the number of slow atrial events

detected equals the programmable Exit Count, ATR Duration and/or Fallback

will be terminated, and the ATR algorithm will be reset.

CAUTION: Exercise care when programming the Exit Count to low values.

Forexample,iftheExitCountwasprogrammedto2,afewcyclesofatrial

undersensing could cause termination of mode switching.

- DRAFT -

5-22 PACING THERAPIES

ATRIAL TACHY RESPONSE

Fallback Mode

Fallback Mode is the nontracking pacing mode that the pulse generator

automatically switches to when ATR Duration is fulﬁlled.

After switching modes, the pulse generator gradually decreases the ventricular

paced rate to the ATR/VTR Fallback LRL, VRR rate, if enabled, or the

sensor-indicated rate if programmed to an adaptive-rate mode, whichever is

higher. The decrease in the ventricular paced rate is controlled by the Fallback

Time parameter.

NOTE: Dual-chamber pacing fallback mode values are only available when

the Normal pacing mode is also set to dual chamber.

Fallback Time

Fallback Time controls how quickly the paced rate will decrease during fallback

to the ATR/VTR Fallback LRL, the sensor-indicated rate, or VRR if enabled.

During fallback, the following features are disabled:

• Rate Smoothing—disabled until fallback reaches the ATR/VTR Fallback

LRL, the sensor-indicated rate, or VRR; if VRR is enabled, then Rate

Smoothing is disabled throughout the mode switch

• Rate Hysteresis

•AVSearch+

• PVARP Extension

All sensor parameters must be programmed when the adaptive-rate Fallback

Mode is selected. When the pulse generator is permanently programmed to

an adaptive-rate mode with an adaptive-rate ATR Fallback Mode, the pulse

generator will use the sensor and sensor parameters already in effect at the

time of the switch. If the pulse generator is permanently programmed to a

nonadaptive rate mode, it is possible to program the ATR Fallback Mode to an

adaptive-rate ATR Fallback Mode using the accelerometer sensor. In this case,

the Accelerometer ﬁeld displays ATR Only.

- DRAFT -

PACING THERAPIES

ATRIAL TACHY RESPONSE 5-23

Fallback LRL

The ATR/VTR Fallback LRL is the programmed lower rate to which the rate

decreases during mode switching.

Consider the following interactions when programming the ATR/VTR Fallback

LRL:

• If an adaptive-rate mode is programmed and the sensor-indicated rate

is greater than the ATR/VTR Fallback LRL, the rate decreases to the

sensor-indicated rate

• If VRR is enabled and the VRR rate is greater than the ATR/VTR fallback

LRL, the rate decreases to the VRR rate

• If an adaptive-rate mode is programmed and VRR is enabled, the rate

will decrease to the faster of the sensor-indicated rate, VRR rate, and the

ATR/VTR Fallback LRL

• The ATR/VTR Fallback LRL is also the Backup VVI pacing rate during

backup pacing in the presence of detected ventricular arrhythmias

End of ATR Episode

The End of ATR Episode identiﬁes the point when the pulse generator reverts

to AV synchronous pacing because the atrial arrhythmia is no longer detected.

The pulse generator continues to pace in the Fallback Mode at the

sensor-indicated rate, the VRR-calculated rate, or the ATR Fallback LRL until

the atrial arrhythmia terminates. With the termination of the arrhythmia, the

ATR Exit Count decrements from its programmed value until it reaches 0.

The ATR Exit Count is decremented by atrial events slower than the ATR

Trigger Rate or any ventricular event that occurs more than two seconds after

the last atrial event. When the ATR Exit Count reaches 0, the pacing mode

automatically switches to the programmed tracking mode, and AV-synchronous

pacing is restored.

Ventricular Tachy Response (VTR)

VTR serves as an automatic mode switch for backup VVI pacing in the

presence of detected ventricular tachyarrhythmias.

- DRAFT -

5-24 PACING THERAPIES

ATRIAL TACHY RESPONSE

When detection is satisﬁed in a ventricular tachycardia zone, the pacing mode

switches to VVI (RV) or to Off if the current mode is AAI(R) or Off.

When the mode switches, backup pacing occurs at the programmed ATR/VTR

Fallback LRL and uses the programmed ATP ventricular Pulse Width and

Amplitude values.

Ventricular Rate Regulation (VRR)

VRR is designed to reduce the V–V cycle length variability during partially

conducted atrial arrhythmias by modestly increasing the ventricular pacing rate.

The VRR algorithm calculates a VRR-indicated pacing interval based on a

weighted sum of the current V–V cycle length and the previous VRR-indicated

pacing intervals.

• Paced intervals have more inﬂuence than sensed intervals such that paced

events cause a decrease in the VRR-indicated rate.

• For sensed intervals, the VRR-indicated rate may be increased; however,

the inﬂuence is tempered by the previous history.

• The VRR-indicated rate is further bound by the LRL and the VRR MPR.

When VRR is programmed on in tracking modes, it is only active when an ATR

mode switch has occurred. Once the tracking mode operation resumes at the

termination of the atrial arrhythmia, VRR becomes inactive. In tracking modes

where both Rate Smoothing and VRR are programmed on, whenever VRR

is active, the pulse generator automatically disables Rate Smoothing, then

reactivates it once the ATR terminates.

When programmed to On in single-chamber modes, VRR is continually active

and updates the following on each cardiac cycle:

• VRR-indicated pacing rate

• Smoothed average

Ventricular Rate Regulation Maximum Pacing Rate (VRR MPR)

The VRR MPR limits the maximum pacing rate for VRR.

VRR operates between the LRL and the MPR.

- DRAFT -

PACING THERAPIES

ATRIAL TACHY RESPONSE 5-25

Atrial Flutter Response (AFR)

Atrial Flutter Response is designed to:

• Prevent pacing into the atrial vulnerable period

• Provide immediate fallback for atrial rates higher than the AFR

programmable rate

The fallback is maintained for as long as atrial events continually exceed the

AFR programmable rate.

Example: When AFR is programmed to 170 ppm, a detected atrial event inside

the PVARP or a previously triggered AFR interval starts an AFR window of

353 ms (170 ppm). Atrial detection inside the AFR is classiﬁed as refractory

senses and is not tracked. Tracking starts only after both the AFR and the

PVARP expire. Paced atrial events scheduled inside an AFR window are

delayed until the AFR window expires. If there are fewer than 50 ms remaining

before a ventricular pace, the atrial pace is inhibited for the cycle.

Ventricular pacing is not affected by AFR and will take place as scheduled. The

wide programmable range for AFR rates allows for appropriate sensing of

slow atrial ﬂutters. High-rate atrial sensing may continuously retrigger the AFR

window, effectively resulting in fallback to the VDI(R) mode.

NOTE: When both AFR and ATR are active and in the presence of atrial

arrhythmias, nontracking ventricular paced behavior may occur sooner, but the

ATR mode switch may take longer.

NOTE: For atrial arrhythmias that meet the programmed AFR rate criteria,

using the AFR feature will result in slower ventricular pacing rates.

PMT Termination

PMT Termination detects and attempts to interrupt pacemaker-mediated

tachycardia (PMT) conditions.

In the DDD(R) and VDD(R) pacing modes, any device may detect and track

retrograde conducted P-waves that fall outside of PVARP, causing triggered

ventricular pacing rates as high as the MTR (i.e., PMT). When PMT Termination

is programmed to On, a PMT condition is detected when 16 successive

ventricular paces are counted at the MTR following atrial sensed events.

- DRAFT -

5-26 PACING THERAPIES

RATE ENHANCEMENTS

During the 16 intervals, the V–A interval is monitored to determine if:

• A PMT is occurring

• The intrinsic atrial rate is simply meeting the MTR or exceeding it

The V–A intervals are compared to the second V–A interval measured during

the 16 ventricular paced events.

• If any of the successive intervals is more than 32 ms shorter or longer

than this second interval, the algorithm continues to monitor successive

ventricular paces for the presence of a PMT

• If the V–A intervals are all within this 32 ms criteria, the rhythm is declared

aPMT

When PMT Termination is programmed to On, the pulse generator stores PMT

episodes in the Arrhythmia Logbook.

When a PMT condition is detected at the MTR, the pulse generator sets the

PVARP setting to a ﬁxed setting of 500 ms for one cardiac cycle in an attempt

to break the PMT. Programming the PVARP After PVC option and/or Rate

Smoothing can also be useful in controlling the pulse generator’s response to

retrograde conduction.

RATE ENHANCEMENTS

Rate Enhancements includes the parameters as described.

Rate Hysteresis

Rate Hysteresis can improve device longevity by reducing the number of

pacing stimuli. In dual-chamber models, this feature is available in DDD, DDI,

VVI, and AAI modes. In single-chamber models, this feature is available in VVI

mode. In DDD, DDI, and AAI modes, rate hysteresis is activated by a single

nonrefractory sensed atrial event. In VVI mode, rate hysteresis is activated by

a single nonrefractory, sensed ventricular event.

Hysteresis is deactivated by the following:

• A single atrial pace at the hysteresis rate

- DRAFT -

PACING THERAPIES

RATE ENHANCEMENTS 5-27

• In DDD mode:

– AsingleatrialpaceduringacardiaccyclewhenanRVpaceis

scheduled at the hysteresis LRL

– An atrial rate that rises above the MTR

NOTE: In VVI mode, hysteresis is deactivated by a single ventricular pace

at the hysteresis rate.

When Rate Smoothing Down is enabled, Rate Hysteresis remains in effect until

pacing occurs at the hysteresis rate. This allows Rate Smoothing to control

the transition to the hysteresis rate.

Hysteresis Offset

Hysteresis Offset is used to lower the escape rate below the LRL when the

pulse generator senses intrinsic atrial activity.

If intrinsic activity below the rate limit occurs, then Hysteresis Offset allows

inhibition of pacing until the LRL minus Hysteresis Offset is reached. As a

result, the patient might beneﬁt from longer periods of sinus rhythm.

Search Hysteresis

When Search Hysteresis is enabled, the pulse generator periodically lowers the

escape rate by the programmed Hysteresis Offset in order to reveal potential

intrinsic atrial activity below the LRL.

During Search Hysteresis, the pacing rate is lowered by the Hysteresis Offset

for up to 8 cardiac cycles. When the search ends, hysteresis remains active

if intrinsic atrial activity is sensed during that period. If there is no intrinsic

atrial activity during the 8-cycle search, pacing resumes at the LRL. If Rate

Smoothing Up is enabled, pacing will rate smooth up to the LRL.

Example: At a rate of 70 ppm and a search interval of 256 cycles, a search

for intrinsic atrial activity would occur approximately every 3.7 minutes

(256 ÷ 70 = 3.7).

Rate Smoothing is disabled during the search cycles. If no intrinsic atrial activity

is detected during the search, the pacing rate is brought up to the LRL. If Rate

Smoothing Up is enabled, the pacing will rate smooth up to the LRL.

- DRAFT -

5-28 PACING THERAPIES

RATE ENHANCEMENTS

NOTE: In VVI mode, the intrinsic activity would be a sensed ventricular event

instead of a sensed atrial event.

Rate Smoothing

Rate Smoothing controls the pulse generator’s response to atrial and/or

ventricular rate ﬂuctuations that cause sudden changes in pacing intervals.

Rate Smoothing is an important enhancement to ATR because it can

signiﬁcantly reduce the rate ﬂuctuations associated with the onset and

cessation of atrial arrhythmias.

Patients who experience large variations in their ventricular paced rate can

feel symptomatic during these episodes. Rate Smoothing can prevent these

sudden rate changes in patients along with the accompanying symptoms (such

as palpitations, dyspnea, and dizziness).

In a normal conduction system, limited cycle-to-cycle rate variations occur.

However, the paced rate can change dramatically from one beat to the next in

the presence of any of the following:

• Sinoatrial disease such as sinus pause or arrest, sinoatrial block, and

brady-tachy syndrome

• PACs and/or PVCs

• Pacemaker Wenckebach

• Intermittent, brief, self-terminating SVTs, and atrial ﬂutter/ﬁbrillation

• Retrogradely conducted P-waves

• Pulse generator sensing of myopotential signals, EMI, crosstalk, etc.

In single-chamber models, Rate Smoothing operates between the LRL and

the MPR when programmed to VVI.

In dual-chamber models, Rate Smoothing operates between the LRL and the

MTR when programmed to DDD or VDD and it operates between the LRL and

MPR when programmed to DDI, VVI, or AAI.

In single-chamber models, when the sensor is enabled, the operational range

is from LRL to MSR. Rate Smoothing is also applicable between the hysteresis

rate and LRL when hysteresis is active, except during Search Hysteresis.

In dual-chamber models, when the sensor is enabled and MSR is higher than

MTR, the operational range is from LRL to MSR. Rate Smoothing is also

- DRAFT -

PACING THERAPIES

RATE ENHANCEMENTS 5-29

applicable between the hysteresis rate and LRL when hysteresis is active,

except during Search Hysteresis.

When Rate Smoothing is programmed to On, the following information applies.

• Programmable Rate Smoothing values are a percentage of the RV

R–R interval (3% to 25% in 3% increments) and can be independently

programmed for:

– Increase—Rate Smoothing Up

– Decrease—Rate Smoothing Down

–Off

• The pulse generator stores the most recent R–R interval in memory.

R-waves may be either intrinsic or paced. Based on this R–R interval

and the programmed Rate Smoothing value, the device sets up two

synchronization windows for the next cycle: one for the atrium and one

for the right ventricle.

NOTE: Single-chamber pulse generators set up a ventricular window.

• Rate Smoothing is functional except:

– During the 8 cycles of rate Search Hysteresis

– During ATR Fallback until fallback reaches the ATR LRL, the

sensor-indicated rate, or the VRR interval

– During VRR when active

– Upon triggering PMT Termination

– Immediately following programmed LRL increases

– When above the MTR

Rate Smoothing Example Based on a Dual-Chamber Tracking Mode

Based on the most recent R–R interval stored in memory and the programmed

Rate Smoothing value, the pulse generator sets up the two synchronization

windows for the next cycle: one for the atrium and one for the ventricle. The

synchronization windows are deﬁned below:

- DRAFT -

5-30 PACING THERAPIES

RATE ENHANCEMENTS

Ventricular synchronization window: previous R–R interval ± Rate

Smoothing value

Atrial synchronization window: (previous R–R interval ± Rate Smoothing

value) - AV Delay

The following example explains how these windows are calculated (Figure 5-13

on page 5-30):

• Previous R–R interval = 800 ms

• AV Delay = 150 ms

• Rate Smoothing Up = 9%

• Rate Smoothing Down = 6%

Thewindowswouldbecalculatedasfollows:

Ventricular Synchronization Window = 800 - 9% to 800 + 6% =

800 ms - 72 ms to 800 ms + 48 ms = 728 ms to 848 ms

Atrial Synchronization Window = Ventricular Synchronization Window - AV

Delay = 728 ms - 150 ms to 848 ms - 150 ms = 578 ms to 698 ms

The timing for both windows is initiated at the end of every ventricular event

(R-R interval).

If paced activity is to occur, it must occur within the appropriate synchronization

window.

Paced AV Delay (150 ms)

trial

Event

Atrial

Event

R-R Interval (800 ms)

RV Event

Atrial Smoothing Window

578 ms 650 ms 698 ms

RV Smoothing Window

728 ms 800 ms 848 msRV Event

Figure 5-13. Rate smoothing synchronization window

It is important to ascertain the patient’s physiologic cycle-to-cycle variation

and program the Rate Smoothing parameter to a value that protects against

pathologic interval changes, yet allows physiologic interval changes in response

to increases in activity or exercise.

- DRAFT -

PACING THERAPIES

LEAD CONFIGURATION 5-31

NOTE: Without Rate Smoothing, a sudden, large atrial rate increase (e.g.,

PAT) will cause a simultaneous sudden increase in the paced ventricular rate

as high as the programmed MTR. With Rate Smoothing, the ventricular paced

rate in response to such a change might not reach the programmed MTR.

Rate Smoothing Up

Rate Smoothing Up controls the largest pacing rate increase allowed when the

intrinsic or sensor rate is increasing.

Rate Smoothing Down

Rate Smoothing Down controls the largest pacing rate decrease allowed when

the intrinsic or sensor rate is decreasing.

NOTE: When Rate Smoothing Down is programmed on and Rate Smoothing

Up is programmed off, the pulse generator will automatically prevent fast

intrinsic beats (e.g., PVCs) from resetting the Rate Smoothing Down escape

rate any faster than 12% per cycle.

Rate Smoothing Maximum Pacing Rate (MPR)

The Rate Smoothing Maximum Pacing Rate places a limit on the maximum

pacing rate that Rate Smoothing can reach.

The Rate Smoothing Down parameter requires a programmed MPR when in

AAI, VVI, or DDI. Rate Smoothing will then be used only between the MPR and

the LRL or the hysteresis rate (if applicable).

When both VRR and Rate Smoothing are programmed on in the VVI(R) or

DDI(R) mode, VRR will have priority; Rate Smoothing will be suspended.

LEAD CONFIGURATION

The pulse generator has independent outputs for the following:

• Atrium (in dual-chamber models)

• Right Ventricle

The atrial and RV leads are set to Bipolar pacing and sensing. The atrial lead

has the option of being programmed Off.

- DRAFT -

5-32 PACING THERAPIES

AV DELAY

AV Delay is the programmable time period from the occurrence of either a

paced or sensed right atrial event to a paced RV event.

AV Delay helps preserve the heart’s AV synchrony. If a sensed ventricular

event does not occur during the AV delay following an atrial event, the pulse

generator delivers a ventricular pacing pulse when AV Delay expires.

AV Delay can be programmed to the following operations:

• Paced AV Delay

• Sensed AV Delay

This behavior occurs under the following conditions:

• Pacing state: Normal, Post-Therapy, or Temporary

• Pacing mode: DDD(R), DDI(R), or VDD(R)

Paced AV Delay

Paced AV Delay corresponds to the AV Delay following an atrial pace.

When the minimum value is less than the maximum value, then the Paced AV

Delay is scaled dynamically according to the current pacing rate. Dynamic AV

Delay provides a more physiologic response to rate changes by automatically

shortening the Paced AV Delay or Sensed AV Delay with each interval during

an increase in atrial rate. This helps minimize the occurrence of large rate

changes at the upper rate limit and allows one-to-one tracking at higher rates.

The pulse generator automatically calculates a linear relationship based on

the interval length of the previous A–A cycle and the programmed values for

the following:

• Minimum AV Delay

• Maximum AV Delay

•LRL

•MTR

•MSR

- DRAFT -

PACING THERAPIES

AV DELAY 5-33

The dynamic AV Delay is not adjusted following a PVC or when the previous

cardiac cycle was limited by the MTR.

When the atrial rate is between the LRL and the higher of the MTR and the

MSR, the pulse generator calculates the linear relationship to determine the

Dynamic AV Delay (Figure 5-14 on page 5-33).

Maximum

AV Delay

Minimum

AV Delay

Higher of MTR

and MSR interval LRL Interval

Dynamic AV Delay

Figure 5-14. Dynamic AV Delay linear relationship

Dynamic AV Delay is activated during Paced AV Delay programming. The AV

delaymaybeprogrammedtoeitheraﬁxed or dynamic value as follows:

• Fixed AV Delay—occurs when Paced AV Delay minimum and maximum

values are equal

• Dynamic AV Delay—occurs when Paced AV Delay minimum and maximum

values are not equal

Sensed AV Delay

Sensed AV Delay corresponds to the AV Delay after a sensed atrial event.

Sensed AV Delay may be programmed to a value shorter than or equal to the

Paced AV Delay. A shorter value is intended to compensate for the difference

in timing between paced atrial events and sensed atrial events (Figure 5-15 on

page 5-34).

- DRAFT -

5-34 PACING THERAPIES

AV DELAY

SAV

PAV

Ap As Vp

Ap = Paced atrial event

As = Sensed atrial event

Vp = Paced ventricular event

SAV = Sensed AV Delay (As-Vp interval)

PAV = Paced AV Delay (Ap-Vp interval)

Figure 5-15. Sensed AV Delay

The hemodynamic impact of the Sensed AV Delay depends on the

appropriateness of the timing between the atrial and ventricular contractions.

An atrial pace starts the atrial contraction, whereas the atrial sense occurs

during the contraction. As a result, when Sensed AV Delay is programmed to

the same value as Paced AV Delay, the hemodynamic AV interval will differ

between paced and sensed atrial events.

Using Sensed AV Delay with Paced AV Delay—Fixed

When Paced AV Delay is programmed to a ﬁxed value (i.e., the minimum and

maximum Paced AV Delay values are the same), then the Sensed AV Delay

will be ﬁxed at the programmed Sensed AV Delay value.

Using Sensed AV Delay with Paced AV Delay—Dynamic

When Paced AV Delay is programmed as dynamic (i.e., the minimum Paced

AV Delay value is programmed at less than the maximum Paced AV Delay

value), then the Sensed AV Delay will also be dynamic.

Dynamic Sensed AV Delay and Paced AV Delay are based on the atrial rate. To

reﬂect the shortening of the PR interval during periods of increased metabolic

demand, the AV Delay shortens linearly from the programmed (maximum)

value at the LRL to a value determined by the ratio of minimum and maximum

AV Delay at the higher of the MTR or MSR (Figure 5-16 on page 5-35). When

Dynamic AV Delay is used, if the Sensed AV Delay value is programmed as

shorter than the maximum Paced AV Delay value, then the Sensed AV Delay

value will also be shorter than the minimum Paced AV Delay value at upper

rates.

- DRAFT -

PACING THERAPIES

AV DELAY 5-35

Maximum

Paced AV

Delay

Minimum

Paced AV

Delay

Shorter of MTR

or MSR Interval LRL Interval Hysteresis Rate

Interval

Paced AV Delay

Sensed AV Delay

Figure 5-16. Dynamic and Sensed AV Delay as a function of the escape interval

NOTE: The minimum value is programmable only in VDD(R) mode.

AV Search+

AV Search+ is designed to promote intrinsic A–V conduction if present; AV

Search + will watch for intrinsic AV conduction to occur beyond the programmed

AV Delay. In patients with exercise-dependent or intermittent AV nodal block,

this intrinsic AV conduction can improve hemodynamic performance and

increase device longevity by reducing the amount of ventricular pacing pulses.

When AV Search+ is enabled, the AV Delay is lengthened periodically

(according to the programmed value) for up to 8 consecutive paced or sensed

cardiac cycles. The AV Search+ AV delay remains active as long as the

intrinsic PR intervals are shorter than the maximum programmed Search AV

Delay value.

The pulse generator reverts to the programmed AV Delay at the following points:

• When the 8-cycle search expires without sensing intrinsic ventricular activity

• When two ventricular paced events occur within the 10-cycle window.

- DRAFT -

5-36 PACING THERAPIES

REFRACTORY

Search AV Delay

The Search AV Delay parameter determines the length of the sensed and

paced AV delays during the search cycles and during the AV hysteresis period.

NOTE: The Search AV Delay value must be programmed to longer than the

maximum Paced AV Delay.

Search Interval

The Search Interval controls the frequency at which AV Search+ will attempt a

search.

REFRACTORY

Refractory includes the features as described.

A-Refractory (PVARP)

PVARP is deﬁnedaccordingtothepacingmode:

Single-chamber atrial modes: AAI(R)—the time period after a sensed or

paced atrial event when an atrial sense event does not inhibit an atrial pace.

Dual-chamber modes: DDD(R), DDI(R), VDD(R)—the time period after a

sensed or paced RV event when an atrial event does not inhibit an atrial

pace or trigger a ventricular pace. The atrial refractory period prevents atrial

sensing and tracking of retrograde atrial activity initiated in the ventricle.

A long atrial refractory period shortens the brady atrial sensing window.

Programming long atrial refractory periods in combination with certain AV Delay

periods can cause 2:1 block to occur abruptly at the programmed MTR.

In DDD(R) and VDD(R) pacing modes, the pulse generator may detect

retrograde conduction in the atrium, causing triggered ventricular pacing rates

as high as the MTR (i.e., PMT). Retrograde conduction times may vary over

a patient’s lifetime as a function of changing autonomic tone. If testing does

not reveal retrograde conduction at implantation, it may still occur at a later

time. This problem can usually be avoided by increasing the atrial refractory

period to a value that exceeds the retrograde conduction time. In controlling

the pulse generator’s response to retrograde conduction, it may also be useful

to program the following:

- DRAFT -

PACING THERAPIES

REFRACTORY 5-37

•PVARPafterPVC

• PMT Termination

• Rate Smoothing

PVARP after PVC

PVARP after PVC is designed to help prevent PMT due to retrograde

conduction, which is typically associated with PVCs.

When the pulse generator detects a sensed RV event without a preceding

sensed or paced atrial event, including sensed events in refractory (i.e., a

PVC), the atrial refractory period automatically extends to the programmed

PVARP after PVC value for one cardiac cycle. After a PVC is detected, the

timing cycles reset automatically. PVARP extends no more frequently than

every other cardiac cycle.

RV-Refractory (RVRP)

The RVRP provides an interval following an RV pace event during which RV

sensed events do not impact the timing of therapy delivery.

The use of a long RVRP shortens the RV sensing window for ventricular tachy

detection.

RVRP is available in any mode where ventricular sensing is enabled, and RVRP

canbeprogrammedtoaﬁxed or dynamic interval (Figure 5-17 on page 5-38):

• Fixed—RVRP remains at the programmed, ﬁxed RVRP value between the

LRL and the applicable upper rate limit (MPR, MTR or MSR).

• Dynamic—RVRP shortens as ventricular pacing increases from the LRL to

the applicable upper rate limit, allowing more time for RV sensing.

– Maximum—if the pacing rate is less than or equal to the LRL (i.e.,

hysteresis), the programmed Maximum VRP is used as the RVRP.

– Minimum—if the pacing rate is greater than or equal to the applicable

upper rate limit, the programmed Minimum VRP us used as the RVRP.

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5-38 PACING THERAPIES

REFRACTORY

Dynamic VRP

shortens

Sensing window

is constant

Figure 5-17. Relationship between ventricular rate and refractory interval

To provide an adequate sensing window, the following refractory value

programming is strongly recommended:

• Single-chamber modes—less than or equal to one-half the LRL in ms

• Dual-chamber modes—less than or equal to one-half the applicable upper

rate limit

Blanking and Noise Rejection

Blanking is the ﬁrst part of the refractory period where sense ampliﬁers are

completely disabled. It is used to prevent cross-chamber sensing and inhibition.

During a blanking interval, the sensing circuit in one chamber ignores sensed

electrical activity generated by a pulse generator pulse in the other chamber

(crosstalk).

• If ventricular pacing were sensed in the atrium, it would initiate an

inappropriately high ventricular pacing rate in any pulse generator

attempting to maintain AV synchrony. Therefore, in DDD(R), DDI(R), and

VDD modes, a ventricular pace initiates a programmable atrial blanking

interval.

• If atrial pacing were sensed in the ventricle, it would inhibit ventricular

pulses and thereby cause an inappropriate decrease in paced rate.

Therefore, in DDD(R) and DDI(R) modes, an atrial pace initiates a

programmable ventricular blanking interval.

RV-Blank after A-Pace

RV-Blank after A-Pace, a cross-chamber blanking period, inhibits RV sensing

following an atrial pace.

- DRAFT -

PACING THERAPIES

REFRACTORY 5-39

If the value is programmed to Smart, the pulse generator automatically

adjusts the sensitivity value in order to reject far-ﬁeld atrial events. This

allows for sensing of true ventricular events that had previously fallen in the

cross-chamber blanking period.

A-Blank after V-Pace

A-Blank after V-Pace, a cross-chamber blanking period, inhibits atrial sensing

following a ventricular pace.

If the value is programmed to Smart, the pulse generator automatically adjusts

the sensitivity value in order to reject far-ﬁeld ventricular events. This allows

for sensing of true atrial events that had previously fallen in the cross-chamber

blanking period.

A-Blank after RV-Sense

A-Blank after RV-Sense, a cross-chamber blanking period, inhibits atrial

sensing following an RV sensed event.

If the value is programmed to Smart, the pulse generator automatically adjusts

the sensitivity value in order to reject far-ﬁeld ventricular events. This allows

for sensing of true atrial events that had previously fallen in the cross-chamber

blanking period.

Refer to the following illustrations:

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5-40 PACING THERAPIES

REFRACTORY

AV Delay after paced atrial event (150 ms)

AV Delay after sensed atrial event (programmable,

includes 85 ms absolute refractory)

Atrial Refractory-PVARP (programmable; includes

programmable atrial cross chamber blank)

V-A interval (may be lengthened by

modified ventricular timing)

V Sensed Refractory (135 ms)

Dynamic Ventricular Refractory (programmable)

Ventricular Cross Chamber Blank (programmable)

sense

V sensed

sense

V paced

pace

V sensed

pace

V paced

ECG

Atrial Channel

Ventricular Channel

Figure 5-18. Refractory periods, dual-chamber pacing modes

A sensed*

V paced

A sensed*

V sensed

A sensed*

V paced

ECG

Atrial Channel

Ventricular Channel

Atrial Sensed Refractory (85 ms)

V Sensed Refractory (135 ms)

Ventricular Refractory (programmable)

Atrial Cross Chamber Blank (programmable)

* An atrial sense occurs during VVI

if an atrial feature is programmed

on (eg, atrial electrograms).

Figure 5-19. Refractory periods, VVI pacing mode

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PACING THERAPIES

NOISE RESPONSE 5-41

Sensed Atrial Refractory-PVARP (programmable;

includes 85 ms absolute refractory)

RV Sensed Refractory (135 ms)

Cross Chamber Blank (programmable

atrial and RV)

Paced Atrial Refractory-PVARP (programmable;

includes 150 ms absolute refractory)

ECG

Atrial Sensing

Ventricular Sensing

A sensed

RV sensed*

A paced

RV sensed*

* An RV sense occurs during AAI

pacing due to the tachycardia

function of the pulse generator.

Figure 5-20. Refractory periods, AAI pacing mode

If the value is programmed to Smart, the pulse generator automatically adjusts

the sensitivity value in order to reject far-ﬁeld ventricular events. This allows

for sensing of true atrial events that had previously fallen in the cross-chamber

blanking period.

NOISE RESPONSE

Noise Response allows you to choose whether to pace or inhibit pacing in

the presence of noise.

A retriggerable, 40-ms noise window exists within each refractory and

cross-chamber blanking period. The window is initiated by either a sensed

or paced event. Both the noise window and the refractory period must be

completed for each cardiac cycle in one chamber before the next sensed

event restarts the timing in the same chamber. Recurrent noise activity may

cause the noise window to restart, extending the noise window and possibly

the effective refractory period or blanking period.

The Inhibit mode is intended for patients whose arrhythmias may be triggered by

asynchronous pacing. If Noise Response is programmed to an asynchronous

mode and the noise persists so that the noise window is extended longer

than the programmed pacing escape interval, the pulse generator paces

asynchronously at the programmed pacing rate until the noise ceases.

RefertoFigure5-21onpage5-42.

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5-42 PACING THERAPIES

NOISE RESPONSE

ECG

RV Sensing

RV Paced

event

RV Sensed

event

Noise window (40 ms)

RV Refractory:

sensed = nonprogrammable

paced = programmable

Figure 5-21. Refractory periods and noise windows, RV

If Noise Response is programmed to Inhibit, and the sensed noise extends the

noise window beyond the programmed paced or sensed interval, the pace

escape interval timing will reset and the pulse generator will not pace until

one escape interval after the noise ceases. The pulse generator will continue

to use a retriggerable noise window. In addition, a Dynamic Noise algorithm

is intended to automatically adjust the maximum sensitivity to avoid noise

detection. This algorithm is active in all rate channels.

If event markers are being transmitted:

Single-Chamber

• The marker [VS] occurs when the noise window is initially triggered

following a V pace

• If retriggered for 340 ms, the marker [VN] occurs

• With continuous retriggers, the marker [VN] occurs frequently

Dual-Chamber

• Depending on the chamber where noise is occurring, the marker [AS] or

[VS] occurs when the noise window is initially triggered following a pace

• If retriggered for 340 ms, the marker [AN] or [VN] occurs

• With continuous retriggers, the marker [AN] or [VN] occurs frequently

NOTE: In pacer-dependent patients, use care when considering setting Noise

Response to Inhibit as pacing will not occur.

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PACING THERAPIES

VENTRICULAR TACHY SENSING INTERACTIONS 5-43

VENTRICULAR TACHY SENSING INTERACTIONS

Refractory periods and blanking intervals are an integral part of the pulse

generator sensing system. They are used to efﬁciently suppress detection of

pulse generator artifacts (e.g., a pace or shock) and certain intrinsic signal

artifacts (e.g., a T-wave or far-ﬁeld R-wave). The pulse generator does not

discriminate between events that occur during refractory periods and blanking

intervals. As a result, all events (pulse generator artifacts, intrinsic artifacts, and

intrinsic events) that occur during a refractory period or blanking interval are

ignored for purposes of pacing timing cycles and ventricular tachy detection.

Certain programmed combinations of pacing parameters are known to interfere

with ventricular tachy detection. When an intrinsic beat from a VT occurs during

a pulse generator refractory period, the VT beat will not be detected. As a

result, detection and therapy of the arrhythmia may be delayed until enough VT

beats are detected to satisfy the tachy detection criteria ("Ventricular Detection

Windows" on page 3-13).

Pacing Parameter Combination Examples

The following examples illustrate the effects of certain pacing parameter

combinations on ventricular sensing. When programming pulse generator

pacing and tachy detection parameters, consider the possible interactions of

these features in light of the expected arrhythmias. In general, the PRM screen

displays Parameter Interaction Attentions and advisory messages to inform you

about programming combinations that could interact to cause these scenarios;

the interactions can be resolved by reprogramming the pacing rate, AV Delay

and/or refractory/blanking periods.

Example 1: Ventricular Undersensing Due to Ventricular Refractory Period

If the pulse generator is programmed as follows, a VT that occurs synchronous

with the pacing will not be detected:

• Brady Mode = VVI

• LRL = 75 ppm (800 ms)

•VRP=500ms

• VT Zone = 150 bpm (400 ms)

In this scenario, the pulse generator is VVI pacing at LRL (800 ms). A 500 ms

VRP follows each ventricular pace. VT beats that occur during VRP are ignored

for purposes of pacemaker timing and ventricular tachy detection/therapy. If

a stable VT of 400 ms starts simultaneously with a ventricular pace, the VT

- DRAFT -

5-44 PACING THERAPIES

VENTRICULAR TACHY SENSING INTERACTIONS

will not be detected because every beat will occur during the 500 ms VRP,

either concurrent with a ventricular pace or 400 ms after a pace (Figure 5-22 on

page 5-44).

NOTE: It is not required for the VT to start concurrently with a pace for

undersensing to occur. In this example, all pacing will be inhibited and tachy

detection will subsequently occur, as soon as a single VT beat is detected.

VP VP VP VP

(VT) (VT) (VT) (VT) (VT) (VT) (VT)

VRP = 500 ms

400 ms

LRL = 800 ms

Figure 5-22. Ventricular undersensing due to VRP

When the programming interaction described in this scenario is present, a

message will describe the interaction of VRP with LRL. In rate-responsive or

tracking modes (e.g., DDDR), similar messages may describe the interaction

of VRP with MTR, MSR, or MPR. Along with each message, the pertinent

programmable parameters are displayed to assist you in resolving the

interaction. Programming Dynamic VRP can be useful in resolving these

types of interactions.

Example 2: Ventricular Undersensing Due To V-Blank After A-Pace

Certain programmed combinations of dual-chamber pacing parameters may

also interfere with ventricular tachy detection. When dual-chamber pacing

occurs, pulse generator refractory periods are initiated by both atrial and

ventricular paces. The ventricular refractory period following a ventricular pace

is controlled by the VRP parameter; the ventricular refractory period following

an atrial pace is controlled by the V-Blank After A-Pace parameter.

Undersensing of a VT due to the pulse generator refractory periods may occur

when the pulse generator is pacing at or above LRL. For example, if the pulse

generator is rate-adaptive pacing at 100 ppm (600 ms) and is programmed

as follows, then a VT that occurs synchronous with the pacing may not be

detected:

• LRL = 90 ppm (667 ms), MTR/MSR = 130 ppm (460 ms)

• Brady Mode = DDDR, ﬁxed AV delay = 300 ms

•VRP=230ms

• V-Blank After A-Pace = 65 ms

- DRAFT -

PACING THERAPIES

VENTRICULAR TACHY SENSING INTERACTIONS 5-45

• VT zone = 150 bpm (400 ms)

In this scenario, the pulse generator is DDDR pacing at 600 ms. A VRP of

230 ms follows each ventricular pace; a ventricular refractory period of 65 ms

(V-Blank After A-Pace) follows each atrial pace; an atrial pace occurs 300

ms after each ventricular pace. VT beats that occur during either refractory

period are ignored for purposes of pacemaker timing and ventricular tachy

detection/therapy. If a stable VT of 350 ms starts, then the VT will not be

detected because most beats will occur during a ventricular refractory period,

either V-Blank After A-Pace or VRP. Some VT beats will be detected, but not

enough to satisfy the 8 of 10 tachy detection criteria ("Ventricular Detection

Windows" on page 3-13).

NOTE: It is not required for the VT to start concurrently with a refractory

period or blanking interval for undersensing to occur. In this example, it is likely

that the VT will not be detected until either the VT accelerates to faster than

350 ms or the sensor-driven pacing rate changes from 600 ms.

VT (VT) (VT) VTVS*

APAP AV = 300 ms

VRP

230 ms

600 ms

350 ms

350 ms700 ms

600 ms 450 ms

Repeat pattern

AP, VP, AP, VS, VT

Figure 5-23. Ventricular undersensing due to V-Blank after A-Pace

When the programming interaction described in this scenario is present, a

message will describe the interaction of Tachy Rate Threshold with LRL and

AV Delay. Similar messages may describe the interaction of V-Blank After

A-Pace with MTR, MPR, or LRL. Along with each message, the pertinent

programmable parameters are displayed to assist you in resolving the

interaction. Programming Dynamic VRP can be useful in resolving these

types of interactions.

- DRAFT -

5-46 PACING THERAPIES

VENTRICULAR TACHY SENSING INTERACTIONS

Programming Considerations

Certain programmed combinations of pacing parameters are known to interfere

with ventricular tachy detection. The risk of ventricular tachy undersensing

due to device refractory periods is indicated by the interactive warnings on

the parameter screen.

As with all device programming, you should evaluate the beneﬁts and the

risks of the programmed features for each patient (for example, the beneﬁt

of Rate Smoothing with a long AV Delay versus the risk of ventricular tachy

undersensing).

The following programming recommendations are provided to reduce the risk

of ventricular undersensing due to the refractory period caused by an atrial

pace (V-Blank after A-Pace):

• If a dual-chamber pacing mode with Rate Smoothing or Rate Adaptive

Pacing is necessary:

– Reduce the LRL

– Shorten the AV Delay or use Dynamic AV Delay and reduce the

minimum Dynamic AV Delay setting

– Reduce the percent AV Search Hysteresis

– Increase the Down Rate Smoothing percentage to the largest possible

value

– Decrease the recovery time for Rate Adaptive Pacing modes

– Reduce the MTR or MPR if Down Rate Smoothing is on

– Reduce the MSR if the pacing mode is rate adaptive

• If Rate Smoothing or Rate Adaptive Pacing are not required for the patient,

consider programming these features Off. Programming these features Off

can reduce the likelihood of atrial pacing at elevated rates.

• If atrial pacing is not required for the patient, consider using VDD rather

than DDD pacing mode.

- DRAFT -

PACING THERAPIES

VENTRICULAR TACHY SENSING INTERACTIONS 5-47

• In certain usage scenarios, you may elect to program long AV Delays to

reduce ventricular pacing for patients with long PR intervals, while providing

sensor pacing or rate smoothing to address other patient needs.

• In certain usage scenarios, if a pattern of atrial pacing and VT beats is

detected, the AV delay is automatically adjusted to facilitate conﬁrmation

of a suspected VT. If no VT is present, the AV delay is returned to the

programmed value. For programming scenarios where the automatic AV

delay adjustment may occur, a speciﬁc Parameter Interaction Attention

will not be displayed.

For discussion of details and additional information regarding these or other

programmed settings, please contact Technical Services at the 24-Hour

Consultation phone number on the back of this manual.

In summary, when programming the pulse generator pacing and tachy

detection parameters, it is useful to consider the possible interactions of these

features in light of the expected arrhythmias of a particular patient. In general,

the interactions will be brought to your attention through Parameter Interaction

Attention messages on the PRM screen and can be resolved by reprogramming

the pacing rate, AV delay, and/or refractory/blanking periods.

- DRAFT -

5-48 PACING THERAPIES

VENTRICULAR TACHY SENSING INTERACTIONS

- DRAFT -

6-1

SYSTEM DIAGNOSTICS

CHAPTER 6

This chapter contains the following topics:

• "Battery Status" on page 6-2

• "Lead Tests" on page 6-6

- DRAFT -

6-2 SYSTEM DIAGNOSTICS

BATTERY STATUS

Pulse generator battery summary information is displayed on the Summary

screen. The Summary screen contains the following components:

• Time Remaining—screen area with the following items:

– Battery status gauge—displays a visual indication of the battery

capacity status, from BOL to explant recommendation

– Approximate Time To Explant––displays the approximate time at which

explant is recommended based on the pulse generator’s programmed

parameters and recent usage history

• Charge Time––displays the amount of time it took the pulse generator

to charge for the most recent maximum-energy shock or capacitor

re-formation

• Battery Detail icon—when selected, this icon displays the Battery Detail

screen

Battery Status Indicators

The following battery status indicators appear in the battery status gauge. All

indicated longevity projections are calculated based on the pulse generator’s

programmed parameters.

• BOL—the pulse generator’s battery is at full capacity.

• One Year Remaining—the pulse generator’s battery has approximately

one year of full function remaining.

- DRAFT -

SYSTEM DIAGNOSTICS

BATTERY STATUS 6-3

• Explant—the pulse generator’s battery is nearing depletion and the pulse

generator has reached the point at which explant is recommended. This

status indicates that pulse generator replacement must be scheduled.

Once Explant status is reached there is sufﬁcient battery capacity to

monitor and pace 100% under existing conditions for three months and to

deliver six maximum-energy shocks. Once the battery capacity is depleted,

pulse generator functionality is degraded.

Once the battery capacity is depleted, the following occurs:

– Number of zones reverts to one ventricular zone (VF) with a rate

threshold of 165 bpm

– ATP therapy and low-energy shocks are unavailable

– The programmed mode reverts to VVI

– LRL defaults to 50 ppm

– The following features are disabled:

– RF telemetry

– Daily measurement trends

– Brady enhancement features

– Episode storage

– Diagnostic and EP tests

– Device programming (Brady Mode and Ventricular Tachy Mode can

be programmed to Off)

– Telemetry interrogation (using a wand) is still available and manual

capacitor re-formation can be selected.

If the device reaches a point where insufﬁcient battery capacity is available

for continued operation, the device will revert to Storage Mode.

NOTE: The device uses the programmed parameters and recent usage

history to predict time to Explant. Greater than normal battery usage may

result in the subsequent day’s approximate time to Explant to appear less

than expected.

- DRAFT -

6-4 SYSTEM DIAGNOSTICS

BATTERY STATUS

Battery Detail Summary Screen

The Battery Detail summary screen provides the following information about

pulse generator battery status (Figure 6-1 on page 6-5):

• Last Delivered Shock––date, energy, charge time, and shock impedance

data

• Beep When Explant Is Indicated––if this feature is programmed to On, the

pulse generator emits 16 beeping tones every six hours after it reaches the

Explant indicator. The tone can then be programmed to Off. Once the

battery capacity is depleted, Beep When Explant Is Indicated is enabled by

the device.

CAUTION: Patients should be advised to contact their physician

immediately if they hear tones coming from their device.

• Last Capacitor Re-form––date and charge time

• Manual Re-form Capacitor––this feature is used to command a capacitor

re-formation when needed.

• Charge Remaining (measured in ampere-hours)––the amount of charge

remaining based on the pulse generator’s programmed parameters until

the battery is depleted.

• Power Consumption (measured in microwatts)––the amount of power being

consumed by the battery based on the pulse generator’s programmed

parameters.

• Power Consumption longevity impact––compares the power consumption

at the pulse generator’s currently programmed parameters with the power

consumption of the parameters used to quote device longevity.

- DRAFT -

SYSTEM DIAGNOSTICS

BATTERY STATUS 6-5

Figure 6-1. Battery Detail summary screen

Capacitor Re-formation

Automatic Capacitor Re-form. Capacitor deformation may occur during

periods when no shocks are delivered, resulting in longer charge times. To

reduce the effect of capacitor deformation on charge time, the capacitors are

automatically re-formed. Tones will not be emitted from the pulse generator

during automatic capacitor re-formations (even if the Beep During Capacitor

Charge feature is programmed to On). During a capacitor re-formation, the

Charge Time is measured and stored for later retrieval.

Manual Capacitor Re-form. Manual capacitor re-forms are not necessary, but

may be commanded via the PRM as follows:

1. Select the Manual Re-form Capacitor button on the Battery Detail screen

and ensure that telemetry communication is established. A message

will appear indicating that the capacitors are charging. Warbling tones

from the pulse generator (if the Beep During Capacitor Charge feature is

programmed to On) will sound while the capacitors are charging.

2. The entire re-form cycle typically takes less than 15 seconds. After

completion of the cycle, the capacitor energy is delivered to the pulse

generator’s internal test load. The initial Charge Time is displayed on the

Battery Detail screen.

Charge Time Measurement

The pulse generator measures the Charge Time whenever its capacitors

charge. The last measured value is stored in pulse generator memory and

displayed by the PRM system on the Battery Detail screen.

- DRAFT -

6-6 SYSTEM DIAGNOSTICS

LEAD TESTS

Last Delivered Ventricular Shock

When a shock has been delivered to the patient, the following information

from the last shock delivered is stored in the pulse generator’s memory and

displayed on the Battery Detail screen:

•Date

• Energy level

•Chargetime

• Shocking lead impedance

This does not include auto capacitor re-forms or shocks that may have been

diverted. If a fault condition is encountered (i.e., high or low impedance), the

fault will be indicated so that corrective action may be taken.

NOTE: For shocks of 1.0 J or less, the accuracy of the impedance

measurement decreases.

LEAD TESTS

The following lead tests are available (Figure 6-2 on page 6-6):

• Pace Impedance

• Shock Impedance

• Intrinsic Amplitude

• Pace Threshold

Figure 6-2. Lead Tests screen

Lead tests can be accessed by using the following steps:

- DRAFT -

SYSTEM DIAGNOSTICS

LEAD TESTS 6-7

1. From the main screen, select the Tests tab

2. From the Tests screen, select the Lead Tests tab

All lead tests may be performed following two different processes:

• ViatheLeadTestsscreen––allowsyoutoperformthesameleadtests

across all chambers

• By selecting the desired chamber button––allows you to perform all tests

onthesamelead

Intrinsic Amplitude Test

The intrinsic amplitude test measures the intrinsic P- and R-wave amplitudes

for the respective chambers.

An intrinsic amplitude test can be performed from the Lead Tests screen by

completing the following steps:

1. You may change the following preselected values as necessary to elicit

intrinsic activity in the chamber(s) being tested:

• Programmed Normal Brady Mode

• LRL at 30 ppm

• AV Delay at 300 ms

2. Select the Intrinsic Amplitude button. During the test, a window will display

the test’s progress. Selecting and holding the Intrinsic Amplitude Button will

cause measurements to be repeated for up to 10 seconds until the button is

released. When the window closes, the same test can be performed again

by selecting the Intrinsic Amplitude button. To cancel the test, select the

Cancel button or press the DIVERT THERAPY key on the PRM.

3. When the test is complete, the intrinsic amplitude measurement will be

displayed. If the test is repeated, the measurements from the previous

session’s test and the current test will be displayed.

NOTE: The test results from the last measurement are stored in pulse

generator memory, retrieved during the initial interrogation, and displayed on

the Lead Tests screen. The measurements are also provided on the Quick

Notes report.

- DRAFT -

6-8 SYSTEM DIAGNOSTICS

LEAD TESTS

Lead Impedance Test

A lead impedance test can be performed and used as a relative measure of

lead integrity over time.

A shock impedance test is a useful tool in detecting shocking lead integrity

changes over time. Evaluating this information together with the Last Delivered

Shock impedance (displayed on the Battery Detail screen) or a subsequent

high-energy shock impedance and other non-invasive diagnostic techniques

may help troubleshoot potential lead system conditions.

Pace and Shock lead impedance tests can be performed from the Lead Tests

screen by completing the following steps:

1. Select the desired lead impedance test button. Selecting and holding a

button will cause measurements to be repeated for up to 10 seconds until

the button is released.

2. During the test, a window will display the test progress. When the window

closes, the same test can be performed by once again selecting the desired

lead impedance test button. To cancel the test, select the Cancel button or

press the DIVERT THERAPY key on the PRM.

3. When the test is complete, the impedance measurement will be displayed.

If the test is repeated, the impedance measurements from the previous

session’s test and the current test will be displayed.

NOTE: The test results from the last measurement are stored in pulse

generator memory, retrieved during the initial interrogation, and displayed on

the Lead Tests screen. The measurements are also provided on the Quick

Notes report.

Pace Threshold Test

The Pace Threshold Test determines the minimum pace amplitude and/or

pulse width needed for capture in a speciﬁc chamber. The minimum 2x voltage

or 3x pulse width safety margin is recommended for each chamber based

on the capture thresholds, which should provide an adequate safety margin

and help preserve battery longevity.

Manual Pace Threshold Test

- DRAFT -

SYSTEM DIAGNOSTICS

LEAD TESTS 6-9

Thetestbeginsataspeciﬁed starting value and steps that value down

(amplitude or pulse width) as the test progresses. The PRM beeps with each

decrement. The values used during the threshold test are programmable.

The parameters are only in effect during the test. Testing for a chamber is

allowed only when pacing is active for that chamber in the mode speciﬁed in

the start column.

NOTE: The starting values for Amplitude and Pulse Width values are

automatically calculated. The device retrieves the stored results for the

previous pace threshold measurement (for the parameter being tested) and

sets the parameter at three steps above the previous threshold measurement.

The LRL is preselected at 90 ppm. For DDD mode, the LRL is further limited

to 10 ppm below the MTR.

NOTE: If DDD mode is chosen, selecting either the atrial or ventricular test

will cause the pacing output to decrease only in the chamber selected.

NOTE: When DDD mode and a ventricular test are selected, only the

pacing output of the ventricular chamber decreases; the atrium is paced at a

continuous amplitude.

Once the test is started, the device operates with the speciﬁed brady

parameters. Using the programmed number of cycles per step, the device

then decrements (steps down) the selected test type parameter (Amplitude or

Pulse Width) until the test is complete. Real-time electrograms and annotated

event markers, which include the values being tested, continue to be available

during threshold testing. The display will automatically adjust to reﬂect the

chamber being tested.

During the threshold test, the programmer displays the test parameters in a

window while the test is in progress. To pause the test or perform a manual

adjustment, select the Hold button on the window. Select the + or −button to

manually increase or decrease the value being tested. To continue the test,

select the Continue button.

The threshold test is complete and all parameters are returned to the normal

programmed values when any of the following occur:

• The test is terminated via a command from the PRM (e.g., pressing the End

Test button or DIVERT THERAPY key)

• The lowest available setting for Amplitude or Pulse Width is reached and

the programmed number of cycles has completed

- DRAFT -

6-10 SYSTEM DIAGNOSTICS

LEAD TESTS

• Telemetry communication is interrupted

A pace threshold test can be performed from the Lead Tests screen using

the following steps:

1. Select the desired chamber to be tested

2. Select the Pace Threshold details button

3. Select the test type

4. Change the following parameter values as desired to elicit pacing in the

chamber(s) being tested:

• Mode

•LRL

• Paced AV Delay

• Amplitude

• Pulse Width

• Cycles per Step

For DDD mode, the normal Brady MTR is used.

5. Watch the ECG display and stop the test by selecting the End Test button

or pressing the DIVERT THERAPY key when loss of capture is observed.

If the test continues until the programmed number of cycles at the lowest

setting have occurred, the test is automatically terminated. The ﬁnal

thresholdtestvaluewillbedisplayed(thevalueisonestepabovethevalue

when the test was terminated).

NOTE: The threshold test result can be edited by selecting the Edit Today’s

Test button on the Threshold Test screen

6. To perform another test, make changes to the test parameter values if

desired, then begin again. Results of the new test will be displayed.

NOTE: The test results from the most recent measurement are stored in

pulse generator memory, retrieved during initial interrogation, and displayed on

the Lead Tests screen and on the Lead Status screen. The measurements are

also provided on the Quick Notes report.

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7-1

PATIENT DIAGNOSTICS

CHAPTER 7

This chapter contains the following topics:

• "Therapy History" on page 7-2

• "Trends" on page 7-3

• "Arrhythmia Logbook" on page 7-5

• "Patient Triggered Monitor" on page 7-13

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7-2 PATIENT DIAGNOSTICS

THERAPY HISTORY

The pulse generator automatically records detection and therapy information

for each detected episode. This data can be reviewed at various levels of

detail using the PRM.

History data storage includes the following information for each episode:

• Episode detail

• Electrograms with annotated markers

• Intervals

The data includes information from all active electrodes. The device

compresses the history data to store a maximum of 17 minutes of electrogram

data (13 minutes with Patient Triggered Monitor enabled). However, the

amount of time actually stored may vary based on the data being compressed

(e.g., noise on the EGM or an episode of VF).

The priority, maximum number, and minimum number of episodes to be stored

by the device for each episode type under normal conditions are speciﬁed

(Table 7-1 on page 7-3). The device stores up to the maximum number of

episodes for a speciﬁc episode type, unless the device memory is ﬁlled up ﬁrst.

The minimum number of episodes for each episode type protects a few low

priority episodes from high priority episodes when device memory is full.

Once the device memory available for episode data is ﬁlled, the device attempts

to prioritize the types of stored episodes and overwrite the stored episodes

according to the following rules:

• If the device memory is full, and there are episode types that have more

than the minimum number of episodes listed in the table, then the oldest

of the lowest priority episodes from these episode types will be deleted.

In this case, the low priority episodes are not deleted if their number of

episodes is less than the minimum number listed in the table.

• If the device memory is full, and there are no episode types that have more

than the minimum number of episodes listed in the table, then the oldest of

the lowest priority episodes of all episode types will be deleted.

• For non-commanded episodes, the episode type for VT-1, VT, and VF

episodes is determined according to the zone Duration that expires

ﬁrst. If no zone Duration expires during an episode, the episode type

is nonsustained.

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PATIENT DIAGNOSTICS

TRENDS 7-3

• An episode in progress has the highest priority until its type can be

determined.

Table 7-1. Episode Priority

Episode Type Priority Minimum number of

episodes stored

Maximum number

of episodes stored

VF 1 510

Patient Triggered

Monitor

111

VT/VT-1 235

Cmd V 302

NonSustV 312

ATRa413

PMTa413

a. Not available in VR models.

Once the history data is saved to a disk, it can be accessed at any time without

device interrogation.

TRENDS

Trends provide a graphical view of speciﬁc patient and device data. This data

can be useful when evaluating your patient’s condition and the effectiveness of

programmed parameters. The following trends are available:

• Events––displays both atrial and ventricular events.

• Heart Rate––displays a trend of the patient’s heart rate. Intervals used in

this calculation must be valid sinus rhythm intervals. The validity of an

interval and the Heart Rate Trend data for the 24-hour collection period is

determined by the Heart Rate Trend collection criteria.

• Activity Level––displays a measure of the patient’s daily activity.

• Atrial Burden––the amount of time spent in an ATR mode switch.

• Respiratory Rate ––provides a trend of the patient’s daily respiratory rate.

• Amplitude––provides amplitude measurements

• Impedance––provides impedance measurements

Follow the steps below to access Trends:

1. From the Events screen, select the Trends Tab

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7-4 PATIENT DIAGNOSTICS

TRENDS

2. Choose the Select Trends button to specify the trends you want to view.

You can choose from the following categories:

• Atrial Arrhythmia––includes Events, Heart Rate, and Atrial Burden

trends

• Activity––includes Heart Rate, Activity Level, and Respiratory Rate

trends

• Custom––allows you to select three trends to customize the information

displayed on the Trends screen

Thedisplayonthescreencanbeviewedinthefollowingmanners:

• Select the desired time on the View button to choose the length of visible

trend data.

• Adjust the start and end dates by moving the slider bar at the top of

the window. You can also adjust these dates by selecting the left- and

right-arrow buttons.

• Move the vertical axis across the graph by moving the slider bar at the

bottom of the display window.

Heart Rate Trend Collection Criteria

Only valid sinus rhythm intervals are used in the heart Rate Trend data

calculations. For Heart Rate Trend, valid intervals are those which include

only valid Heart Rate Trend events. Heart Rate Trend event validation criteria

are listed below:

Valid Heart Rate Trend Events Invalid Heart Rate Trend Events

AS with an interval not faster than

MTR, followed by a VS

AS followed by VP at the programmed

AV Delay

AS with an interval faster than MTR

Non-tracked VP events

Consecutive AS events (no

intervening V event)

VP-Ns

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PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK 7-5

Rate Smoothing events (e.g., RVP↑)

PVC

Heart Rate Trend data may not be reported for a variety of reasons; the most

common are as follows:

• Less than 67% of the 24-hour collection period (approximately 16 hours)

contains valid Heart Rate Trend events

• Brady parameters were programmed within the last 24 hours

ARRHYTHMIA LOGBOOK

The Arrhythmia Logbook screen provides the following information about each

event (Figure 7-1 on page 7-5):

• The number, date, and time of the event

• The type of event with zone

• A summary of therapy delivered or attempted (if applicable)

• Whether or not intervals and EGMs are stored as indicated by the presence

of details button

• Duration of the event

Figure 7-1. Arrhythmia Logbook screen

To display Arrhythmia Logbook data, use the following steps:

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7-6 PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK

1. From the Events tab, select Arrhythmia Logbook. If necessary, the pulse

generator will be automatically interrogated and current data will be

displayed. Data from a patient disk also can be displayed:

a. Select the Utilities button on the toolbar.

b. From the Utilities screen, select the Disk tab. Choose the Read Disk

option.

2. While retrieving the data, the programmer will display a window indicating

the progress of the interrogation. No information will be displayed if you

select the Cancel button before all of the stored data are retrieved.

3. Use the slider and View button to control the range of dates for the events

youwanttodisplayinthetable.

4. Select the Details button of an event in the table to display the event

details. Event details, available if the details button is present, are useful in

evaluating each detection or therapy sequence.

5. To sort events by date, type, therapy, or duration, select the corresponding

column header button. To reverse the order, select the column header

again.

6. To save speciﬁc events, select the event and choose the Save to Disk

button. To print speciﬁc events, select the event and choose Reports from

the toolbar. Choose the selected Episodes Report and select the Print

button.

NOTE: An “in-progress” episode will not be saved; an episode must be

complete before it will be saved by the application.

Events Summary

The Events Summary screen displays additional details about the selected

episode corresponding to the Arrhythmia Logbook.

The summary data include the following:

Episode Details

• Episode number, date, time, type (VF, VT, VT-1, spontaneous/induced, or

PTM indicating a Patient Triggered Monitor episode)

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PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK 7-7

• Average atrial and ventricular rates

• Type of therapy delivered

• For ATP therapy, the time of therapy delivery and the number of bursts

• For shock therapy, the start time of charging, charge time, impedance,

energy level

• Time the episode ended

ATR Episodes

• Episode number, date, time, and type (ATR)

• Average atrial and ventricular rate during ATR mode switch

• Duration

PMT Episodes

• Episode number, date, time, and type (PMT)

• Atrial rate at PMT start

• Average atrial and ventricular rates

Follow the steps below to view episode detail:

1. Select the desired episode on the Arrhythmia Logbook screen. The Stored

Event screen will appear.

2. From the Stored Event screen, select the EGM tab to view the detailed

information for this episode.

3. Select the Previous Event or the Next Event button to display a previous

or more current episode, one episode at a time.

4. Select the Print Event button to print the episode detail being viewed.

5. Select the Save to Disk button to save the episode detail to a patient data

disk.

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7-8 PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK

Stored Electrograms

The pulse generator can store annotated electrograms sensed from the

following leads prior to the onset of an episode around duration met, and

around therapy start and end:

• Shock lead

• RV pace/sense lead

• Atrial pace/sense lead

The particular electrograms stored depend upon the episode type. The EGM

storage capacity varies depending on EGM signal condition and heart rate.

The stored data are shared by all events. The total amount of stored EGM

data associated with an episode may be limited; EGMs from the middle of the

episode may be removed for episodes greater than 4 minutes in duration.

When the memory allocated to EGM storage is full, the device overwrites older

EGM data segments in order to store the new EGM data. The EGM is recorded

in segments consisting of episode Onset, Attempt, and End EGM storage.

Each segment of data is visible when the left caliper is in the speciﬁc section.

The following information is retained:

• Onset retains up to 25 seconds of data prior to Duration expiring

• Reconﬁrmation retains up to 20 seconds of data prior to therapy delivery

• Therapy data is displayed. In the case of ATP therapy, a maximum of 4

bursts and up to 20 seconds of data, for each burst, will be retained

• Post-therapy or diverted therapy retains up to 10 seconds of data

Episode onset refers to the period of time (measured in seconds) of EGM prior

to the ﬁrst attempt. Onset includes the following information:

• Type of event

• Average RA Rate at the start of Event

• Average RV Rate at start of Event

• Programming of Detection Enhancements (Rate only, Rhythm ID, or

Onset/stability)

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PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK 7-9

Attempt information may be displayed as Attempt or In Progress, if an attempt

is in progress. Attempt includes the following information:

• Detection information:

– Average RA Rate at start of Attempt

– Average RV Rate at start of Attempt

–RateZone

• Measured Values of Detection Enhancements

• Therapy Attempt Information:

– Attempt Number

– Type (diverted, commanded, or inhibited)

– Number of bursts (ATP attempt)

–Chargetime

– Lead impedance

– Lead polarity

– Shock faults

– Reason for No Therapy

The End EGM storage starts following therapy delivery and stores up to 10

seconds of EGM (Figure 7-2 on page 7-9).

Onset after

3 fast beats

Duration expires Charging begins Start End-of-

Episode timer

End-of-Episode

times out.

Episode is over.

5 s 10 s 10 s 10 s 10 s 10 s 10 s 10 s

Note: Charging may begin

when duration expires.

Shock

Figure 7-2. Relationship between ventricular tachy episode EGM storage and surface ECG strip chart

recording

To view the EGM data, select the desired episode on the Arrhythmia Logbook

screen. Use the following steps to view speciﬁc details about each episode:

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7-10 PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK

1. Select the EGM tab to view the stored EGMs on the screen.

• EGM strips for the appropriate sources are displayed. Each strip

includes the EGMs sensed during the episode with the corresponding

annotated markers. Blue vertical bars indicate the segment (Onset,

Attempt, End) boundaries.

• You can move the calipers along the trace and will display the time

interval between the calipers.

• A speed button changes the trace speed in millimeters/seconds.

2. Select the Previous Event or Next Event button to display a different event

strip. If EGMs are not available for an episode, the Episode Detail screen

will be displayed.

3. To print the entire episode report, select the Print Event button. To save the

entire episode report, select the Save to Disk button.

NOTE: Refer to "Use of Atrial Information" on page 3-5 for additional

information about device performance when the atrial lead is programmed to

Off.

Intervals

The pulse generator stores event markers and associated time stamps. The

PRM derives event intervals from the event markers and time stamps.

To view the episode intervals, use the following steps:

1. From the Stored Event screen, select the Intervals tab. If all of the episode

data is not visible in the window, use the scroll bar to view more data.

2. Select the Previous Event or the Next Event button to display a previous

or more current episode, one episode at a time.

3. Select the Print Event button to print the entire episode report.

4. Select the Save to Disk button to save the entire episode report to a patient

data disk.

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PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK 7-11

Histograms

The Histograms feature retrieves information from the pulse generator and

displays the total number and percentage of paced and sensed events for

the chamber.

Histograms data can provide the following clinical information:

• The distribution of the patient’s heart rates

• How the ratio of paced to sensed beats varies by rate

• How the ventricle responds to paced and sensed atrial beats across rates

Use the following steps to access the Histograms screen:

1. From the Events screen, select the Patient Diagnostics tab.

2. The initial display shows the paced and sensed data since the last time the

counters were reset.

3. Select the Details button to display the data type and time period.

4. Select the Rate Counts button on the Details screen to view rate counts

by chamber.

Counters

The following counters are recorded by the pulse generator and displayed on

the Patient Diagnostics screen:

• Ventricular Tachy

• Brady

Ventricular Tachy Counters

Information about Ventricular Tachy Counters is available by selecting the

Ventricular Tachy Counters button. This screen displays both Ventricular Tachy

Episode and Therapy counters. For each counter, the number of events since

last reset and device totals are displayed. Ventricular Tachy Episode counters

contains the following data:

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7-12 PATIENT DIAGNOSTICS

ARRHYTHMIA LOGBOOK

• Total episodes

• Treated––VF, VT, VT-1, and Commanded

• Nontreated––No Therapy Programmed, Nonsustained, and Other

Untreated Episodes

Ventricular Tachy Therapy counters consist of ventricular shock and ATP

therapy attempts. They can provide useful data about the effectiveness of a

patient’s therapy prescription. These counters include the following information:

• ATP Delivered

• ATP % Successful––the percent of time that the arrhythmia is converted

and the episode ends without delivery of a programmed shock

• Shocks Delivered

• First Shock % Successful––the percent of time that the arrhythmia is

converted and the episode ends without requiring a second programmed

shock

•ShocksDiverted

The ventricular ATP counter is incremented at the start of the delivery of the

ﬁrst burst of an ATP scheme. Subsequent ATP bursts in the same scheme are

not counted individually during the same episode.

An ATP scheme is counted as diverted only if it is diverted prior to delivery

of the ﬁrst burst.

Brady Counters

Information about Brady Counters are displayed by selecting the Brady

Counters button. This screen displays the brady episode counters. For each

counter, the number of events since last reset and reset before last are

displayed. Brady counters contains the following details:

• Percent of atrial paced

• Percent of RV paced

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PATIENT DIAGNOSTICS

PATIENT TRIGGERED MONITOR 7-13

• Intrinsic Promotion––includes Rate Hystereses % successful and AV

Search+ % successful

• Atrial burden––includes Episodes by Duration and Total PACs

• Ventricular counters––includes total PVCs and Three or More PVCs

PATIENT TRIGGERED MONITOR

Patient Triggered Monitor allows the patient to trigger the storage of EGMs,

intervals, and annotated marker data during a symptomatic episode by placing

a magnet over the device.

Patient Triggered Monitor is enabled by selecting Store EGM as the desired

magnet response. This can be found in the Magnet and Beeper section on the

V-Tachy Therapy Setup screen. When enabled, the device will store up to 2

minutes of patient monitor data prior to and up to 1 minute after triggering

the monitoring. The stored data include the episode number, the atrial and

ventricular rates at magnet application, and the start time and date of magnet

application.

When data are stored, the corresponding episode type is recorded as PTM

in the Arrhythmia Logbook.

Use care when enabling Patient Triggered Monitor, because the following

conditions will exist:

• All other magnet features are disabled, including inhibiting therapy (until

the EGM is stored). The Magnet/Beeper feature will not indicate magnet

position.

• Device longevity is impacted. Once the patient has triggered this feature to

store episode data or the feature is disabled, the impact on device longevity

is no longer present. To help reduce the longevity effect, this feature is

automatically disabled after 60 days from the day it was enabled.

• Once the EGM is stored, the device magnet response automatically will be

set to Inhibit Therapy.

To program the Patient Triggered Monitor feature, follow these steps:

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7-14 PATIENT DIAGNOSTICS

PATIENT TRIGGERED MONITOR

1. From the Settings tab on the main screen, select Settings Summary.

2. From the Settings Summary tab, select Ventricular Tachy Therapy.

3. From Ventricular Tachy Therapy, select the V-Tachy Therapy Setup details

button.

4. Program the Magnet Response to Store EGM.

CAUTION: Determine if the patient is capable of activating this feature

prior to being given the magnet and prior to enabling Patient Triggered

Monitor. Remind the patient to avoid strong magnet ﬁelds so the feature is

not inadvertently triggered.

CAUTION: Consider having the patient initiate a stored EGM at the time

Patient Triggered Monitor is enabled to assist with patient education and

feature validation. Verify the activation of the feature on the Arrhythmia

Logbook screen.

WARNING: Ensure that Patient Triggered Monitor is enabled prior

to sending the patient home by conﬁrming the magnet response is

programmed to Store EGM. If the feature is inadvertently left in the Inhibit

Therapy setting, the patient could potentially disable tachyarrhythmia

detection and therapy.

WARNING: Once the Patient Triggered Monitor feature has been

triggered by the magnet and an EGM has been stored, or after 60 days

have elapsed from the day that Store EGM was enabled, the Magnet

Response programming automatically will be set to Inhibit Therapy.

When this happens, the patient should not apply the magnet because

tachyarrhythmia therapy could be inhibited.

NOTE: When the Magnet Response programming has automatically

been set to Inhibit Therapy, magnet application will cause the device to

emit beeping tones. Inform the patient that if they hear tones coming from

their device after applying the magnet, they should remove the magnet.

5. Patient Triggered Monitor can only be enabled for a 60-day period of time.

To disable the feature within the 60-day time period, reprogram the magnet

response to a setting other than Store EGM. When 60 days have passed

since enabling Patient Triggered Monitor, the feature will automatically

disable itself and the magnet response will revert to Inhibit Therapy. To

re-enable the feature, repeat these steps.

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PATIENT DIAGNOSTICS

PATIENT TRIGGERED MONITOR 7-15

For additional information, contact Technical Services at the number shown on

the back cover of this manual.

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7-16 PATIENT DIAGNOSTICS

PATIENT TRIGGERED MONITOR

- DRAFT -

8-1

ELECTROPHYSIOLOGIC TESTING

CHAPTER 8

This chapter contains the following topics:

• "EP Test Features" on page 8-2

• "Induction Methods" on page 8-4

• "Commanded Therapy Methods" on page 8-10

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8-2 ELECTROPHYSIOLOGIC TESTING

EP TEST FEATURES

Electrophysiologic (EP) Testing features enable you to induce and terminate

arrhythmias noninvasively in order to monitor and test the effectiveness of

selected detection criteria and therapies. The EP Test features can be used in

conjunction with the ECG display so that real-time traces may be viewed. The

status of the pulse generator/patient interaction is also displayed.

The features allowing noninvasive EP testing of arrhythmias include the

following:

• VFib induction

• Shock on T induction

• PES induction

• 50 Hz/Manual Burst pacing induction

• Commanded Shock therapy

• Commanded ATP therapy

Temporary EP Mode

Temporary EP Mode allows you to program the device mode to a temporary

value for EP test delivery, and ensures that the normal device mode remains

unchanged.

Backup Ventricular Pacing During Atrial EP Testing

Backup ventricular pacing is available during atrial EP testing (PES, 50

Hz/Manual Burst) regardless of the programmed Normal or Post-therapy

pacing modes. (The mode can also be programmed to Off.) Program the

backup pacing parameters by selecting the EP Test Pacing button displayed on

the relevant atrial EP tests.

EP Test Screen

The EP Test screen displays the real-time status of the detection and therapy

process of the pulse generator when telemetry communication is occurring.

Viewing this display allows you to induce and test either a programmed

detection/therapy prescription or optional therapies while monitoring the pulse

generator’s progress.

Refer to the EP Test screen (Figure 8-1 on page 8-3):

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ELECTROPHYSIOLOGIC TESTING

EP TEST FEATURES 8-3

Figure 8-1. EP Test Screen

The screen provides the following information:

• Status messages indicate detection and therapy status and are described

below:

– Ventricular episode status—if an episode is occurring, the duration of

the episode is displayed. (If it is greater than 10 minutes, then it is

displayed as > 10:00 m:s).

– Ventricular detection status—if an episode is occurring, it indicates

whether ventricular detection is in Initial Detection, Redetection, or the

zone in which that detection is met. If no episode is occurring, the

programmer will also display the text Time since last V therapy along

with the continually updated time in minutes (up to 10).

– Brady pacing and SRD status.

– The type of therapy initiated and the zone.

– The status of the therapy such as In progress, Diverted, or Delivered.

• Duration timer—Progression of the duration timer is graphically displayed

using a scale. The bar in the scale moves from left to right to show the

percent complete of programmed duration. When duration is expired and

therapy delivery begins, the bar is removed.

• Detection status—The status for each programmed detection enhancement

is displayed. When enhancement criteria are met, a mark appears in the

adjacent box.

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8-4 ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS

• Therapy prescriptions—Only those therapy prescriptions that are

programmed are displayed. As each therapy is delivered, a check mark

or number will appear in the box adjacent to the respective therapy. ATP

therapies indicate the scheme type as well as the programmed number of

bursts in the scheme. A number will appear and increment (1, 2, etc.) in

the ATP therapy box each time an ATP burst is delivered. Shock therapies

indicate the programmed energy level for the programmable shocks. A

number will appear and increment (1, 2, etc.) in the Max box each time a

maximum-energy shock is delivered.

Follow the steps below to perform EP Test functions:

1. Select the Tests tab, then select the EP Tests tab.

2. Establish telemetry communication. Telemetry communication between the

programmer and the pulse generator should be maintained throughout all

EP test procedures.

3. Program the EP Temp V mode appropriate to the EP Test method

(Table 8-1 on page 8-4).

Table 8-1. EP Temp V Mode for EP Test Functions

EP Temp V Mode

EP Test MethodaMonitor + TherapydMonitor OnlyeOff

50 Hz/Manual BurstbX

PESbX

VFibcX

Shock on TcX

Commanded ATPcX

Commanded ShockcXX

a. EP functions cannot be performed if the pulse generator is in Storage Mode.

b. Available method for both atrial and ventricular induction.

c. Available method only for ventricular induction.

d. The Ventricular Tachy Mode must be programmed to Monitor + Therapy.

e. The Ventricular Tachy Mode must be programmed to Monitor Only or Monitor + Therapy.

INDUCTION METHODS

Each induction method available from the EP Test screen is described below

with instructions for performing the induction. During any type of induction

delivery, the pulse generator recognizes the induction and performs no other

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ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS 8-5

activity until the induction delivery is ceased, at which time the programmed

mode will take effect and the pulse generator will respond accordingly.

Consider the following information when using these methods:

• All inductions and tachycardia therapy delivery are inhibited when a

magnet is positioned over the pulse generator (if magnet response is set to

Inhibit Therapy).

• Pacing pulses during induction are delivered at the programmed EP Test

pacing parameters.

VFib Induction

VFib induction uses the shocking electrodes to stimulate the right ventricle

at very fast rates.

The following settings are available to allow use of the minimum energy

necessary for induction:

• VFib Low delivers a stimulation waveform of 9 volts

• VFib High delivers a stimulation waveform of 15 volts

Performing VFib Induction

NOTE: The patient should be sedated prior to delivery of ﬁbrillation induction

pulses. The large surface area of the shocking electrodes tends to stimulate

the surrounding muscle and can be uncomfortable.

1. Select the VFib option. Buttons for each test and an Enable checkbox

are displayed.

2. Select the Enable checkbox.

3. Select the desired Hold for Fib button to initiate delivery of the ﬁbrillation

induction train. The induction train is delivered up to 15 seconds as long as

the button is held and the telemetry link is maintained.

During induction the pulse generator is automatically disabled from

detecting, and automatically re-enabled following induction delivery.

If VFib induction is initiated during an episode, the end-of-episode is

declared before the VFib induction pulses are started. A new episode (with

initial detection and therapy) can be declared after the VFib induction is

- DRAFT -

8-6 ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS

completed. Event markers and EGMs are interrupted during VFib induction

and will automatically restart following induction.

4. To stop the induction train, release the button (the button will become

dimmed again).

5. To deliver another ﬁbrillation induction, repeat these steps.

Shock on T Induction

A Shock on T wave induction method allows the device to deliver a drive train

(up to 30 equally timed pacing pulses, or S1 pulses) through the ventricular

pace/sense electrodes followed by shock delivery through the shocking

electrodes (Figure 8-2 on page 8-6).

400 400 400 400 400 400

S1 S1 S1 S1 S1 S1

Last sensed or

paced beat

Coupling

Interval

Drive Pulses

Shock

S1 Interval

Figure 8-2. Shock on T induction drive train

The initial S1 pulse follows the last sensed or paced event at the S1 interval.

The shock is coupled to the last S1 pulse of the drive train.

Performing Shock on T Induction

1. Select the Shock on T option. The programmable induction parameters

will be displayed.

2. Select the desired value for each parameter.

3. Select the Enable checkbox. The Induce button will no longer be dimmed.

4. Select the Induce button to begin delivery of the drive train. The pulses are

delivered in sequence until the programmed number of pulses is reached.

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ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS 8-7

Once induction is initiated, the drive train delivery will not stop if you

interrupt telemetry communication. You can press the DIVERT THERAPY

key to stop the induction delivery command.

5. Shock on T induction is complete when the drive train and shock are

delivered, at which time the pulse generator automatically restarts

detection.

NOTE: Prior to drive train delivery, tones will be heard indicating capacitor

charging in preparation for shock delivery.

NOTE: The shock delivered during Shock on T induction does not increment

episode or therapy counters.

Programmed Electrical Stimulation (PES)

PES induction allows the pulse generator to deliver up to 30 equally timed

pacing pulses (S1) followed by up to 4 premature stimuli (S2–S5) to induce or

terminate arrhythmias. Drive pulses, or S1 pulses, are intended to capture and

drive the heart at a rate slightly faster than the intrinsic rate. This ensures that

the timing of the premature extra stimuli will be accurately coupled with the

cardiaccycle(Figure8-3onpage8-7).

The initial S1 pulse is coupled to the last sensed or paced beat at the S1

interval. All pulses are delivered in XOO modes (where X is the chamber) at

the programmed EP Test pacing parameters.

S1 S1 S1 S1 S1 S2 S3

600 400600 600 600 600 450

Coupling

Interval

Coupling

Interval

Extra

Stimuli

Drive Pulses

Figure 8-3. PES induction drive train

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8-8 ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS

Performing PES Induction

1. Select the PES option. Buttons for the S1–S5 pulses and the corresponding

burst cycle lengths are displayed.

2. Select the desired value for the S1–S5 intervals (Figure 8-4 on page 8-8).

You can either select a value box for the desired S interval and choose a

value from the box or use the plus or minus symbols to change the value

visible in the value box.

Figure 8-4. PES induction options

3. Select the Enable checkbox.

4. Select (do not hold) the Induce button to begin delivery of the drive train.

When the programmed number of S1 pulses is delivered, the pulse

generator will then deliver the programmed S2–S5 pulses. The pulses are

delivered in sequence until a pulse is encountered that is set to Off (e.g.,

if S1 and S2 are set to 600 ms, and S3 is Off, then S3, S4, and S5 will

not be delivered). Once induction is initiated, the PES delivery will not

stop if you interrupt telemetry communication. (You can press the DIVERT

THERAPY key to stop induction delivery.) If PES induction is initiated

during an episode, the end-of-episode is declared before the PES induction

pulses are started. A new episode (with initial detection and therapy) can

be declared after the PES induction is completed.

5. PES induction is complete when the drive train and extra stimuli are

delivered, at which time the pulse generator automatically restarts

detection.

NOTE: Ensure the PES induction is complete before beginning another

induction.

NOTE: When PES is used to terminate an arrhythmia that has been detected

(and an episode declared), the episode is terminated when the PES is

commanded regardless of whether it is successful or not. The PES itself is not

recorded in therapy history; this may result in several episodes being counted

in therapy history.

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ELECTROPHYSIOLOGIC TESTING

INDUCTION METHODS 8-9

50 Hz/Manual Burst Pacing

50 Hz/Manual Burst pacing induction is used to induce or terminate arrhythmias

and allows two separate pacing inductions, both of which can be delivered to

either the atrium or ventricle.

Manual Burst pacing pulses are delivered in XOO mode (where X is the

chamber) at the programmed EP Test pacing parameters through the

rate-sensing leads. For Atrial Manual Burst, backup pacing parameters are

provided.

Performing Manual Burst Pacing

1. Select the 50 Hz/Manual Burst option.

2. Select the desired value for the Burst Interval, Minimum, and Decrement.

This indicates the cycle length of the intervals in the drive train.

3. Select the Enable checkbox.

4. To deliver the burst, select and hold the Hold for Burst button.

The ventricular Manual Burst will be delivered up to 30 seconds as long as

the Hold for Burst button is held and the telemetry link is maintained.

The atrial Manual Burst will be delivered up to 45 seconds as long as the

Hold for Burst button is held and the telemetry link is maintained. The

intervals will continue to be decremented until the minimum interval is

reached, then all further pulses will be at the Minimum interval.

5. To stop the burst delivery, release the Hold for Burst button. The Hold for

Burst button will become dimmed again.

6. To deliver additional Manual Burst pacing, repeat these steps.

Performing 50 Hz Burst Pacing

1. Select the 50 Hz/Manual Burst option.

2. Select the Enable checkbox.

3. To deliver the burst, select and hold the Hold for 50 Hz Burst button.

- DRAFT -

8-10 ELECTROPHYSIOLOGIC TESTING

COMMANDED THERAPY METHODS

The ventricular 50 Hz Burst will be delivered up to 30 seconds as long as

the Hold for Burst button is held and the telemetry link is maintained.

The atrial 50 Hz Burst will be delivered up to 45 seconds as long as the

Hold for Burst button is held and the telemetry link is maintained.

NOTE: During Hold for 50 Hz Burst pacing, the S1 interval is automatically

set to 20 ms and the decrement to 0. These values will not be displayed on the

screen.

4. To stop the burst delivery, release the Hold for 50 Hz Burst button. The

Hold for 50 Hz Burst button will become dimmed again.

5. To deliver additional 50 Hz Burst pacing, repeat these steps.

COMMANDED THERAPY METHODS

The commanded EP test methods, Commanded Shock and Commanded ATP,

may be delivered independently of the programmed detection and therapy

parameters. If the pulse generator is in the process of delivering therapy when

a commanded method is initiated, the EP Test function overrides and aborts

the therapy in process. If an episode is not in progress, then a Commanded

Ventricular Episode will be recorded in the Arrhythmia Logbook. Commanded

Shock and Commanded ATP delivery is inhibited when a magnet is positioned

over the pulse generator, if it is programmed to Inhibit Therapy.

Commanded Shock

The Commanded Shock feature allows delivery of a shock with programmable

energy and coupling interval.

All Commanded Shocks are Committed and delivered R-wave synchronously

when the coupling interval is programmed to Sync. Shock waveform and

polarity are identical to detection-initiated shocks but a programmed coupling

interval may be speciﬁed. The coupling interval is initiated at the point where

the shock would have been delivered in Sync mode, but is instead delivered at

the programmed coupling interval. Following any Commanded Shock delivery,

Post-shock Redetection is used and post-shock pacing is activated.

Performing Commanded Shock Delivery

1. Select the Commanded Shock option.

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ELECTROPHYSIOLOGIC TESTING

COMMANDED THERAPY METHODS 8-11

2. Select the desired values for the Coupling interval and Shock Energy.

3. Select the Enable checkbox. The Deliver Shock button will become

available.

4. Select the Deliver Shock button to initiate shock delivery. The Commanded

Shock is recorded in therapy history.

5. To deliver subsequent shocks, repeat these steps.

Commanded ATP

Commanded ATP allows you to manually deliver ATP schemes, independent

of the programmed detection and therapy parameters. You can conﬁgure

the Commanded ATP by either selecting the type of ATP scheme or by

programming ATP parameters on the Details screen in order to deliver

Commanded ATP.

The EP Temp V Mode must be programmed to Monitor Only to ensure the

Commanded ATP does not interfere with detection-initiated ATP.

Performing Commanded ATP

1. If the pulse generator Ventricular Tachy Mode is not currently programmed

to Monitor Only, select the Monitor Only EP Temp V Mode option.

2. Select the type of ATP scheme and select the value for Number of Bursts.

3. Select the Start ATP button to initiate the ﬁrst burst in the selected ATP

scheme. The Bursts Remaining counter will decrement as each burst is

completed.

4. Select the Continue button for each additional burst delivery desired. If all

bursts in a scheme have been delivered, the Bursts Remaining counter will

return to the initial count, and the Continue button will be dimmed.

5. Other ATP schemes may be selected at any time; select the desired

scheme and repeat the above sequence. The Commanded ATP is

recorded as a physician-commanded therapy counter and displayed on

the counters screen.

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8-12 ELECTROPHYSIOLOGIC TESTING

COMMANDED THERAPY METHODS

6. After using Commanded ATP, remember to program the EP Temp V Mode

to Monitor + Therapy or leave the screen so that the EP Temp V Mode is

ended and the permanent Tachy Mode is resumed.

NOTE: If any button other than the Continue button is selected during delivery

of a Commanded ATP scheme, the scheme will be reset and the Bursts

Remaining box will be restored to its initial value. The Start ATP button must be

reselected to initiate the scheme again.

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9-1

IMPLANT INFORMATION

CHAPTER 9

This chapter contains the following topics:

• "Implanting the Pulse Generator" on page 9-2

- DRAFT -

9-2 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

Step A: Check Equipment

Step B: Interrogate and Check the Pulse Generator

Step C: Implant the Lead System

Step D: Take Baseline Measurements

Step E: Form the Implantation Pocket

Step F: Connect the Leads to the Pulse Generator

Step G: Evaluate Lead Signals

Step H: Program the Pulse Generator

Step I: Implant the Pulse Generator

Step J: Complete and Return the Implantation Form

Step A: Check Equipment

It is recommended that instrumentation for cardiac monitoring, deﬁbrillation,

and lead signal measurement should be available during the implant procedure.

This includes the PRM system with its related accessories and the software

application. Before beginning the implantation procedure, become completely

familiar with the operation of all the equipment and the information in the

respective operator’s and user’s manuals. Verify the operational status of all

equipment that may be used during the procedure. Sterile duplicates of all

implantable items and the following accessories should be available in case of

accidental damage or contamination:

• Internal deﬁbrillator paddles

•Externaldeﬁbrillator paddles

• Torque and non-torque wrenches

During the implantation procedure, a standard transthoracic deﬁbrillator

with external pads or internal paddles should be available for use during

deﬁbrillation threshold testing.

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IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-3

Step B: Interrogate and Check the Pulse Generator

To maintain sterility, test the pulse generator as described below before opening

the sterile blister tray. The pulse generator should be at room temperature to

ensure accurately measured parameters.

1. Interrogate the pulse generator using the PRM. Verify that the pulse

generator’s Tachy mode is programmed to Storage. If otherwise, call

Technical Services at the phone number provided on the back of this

manual.

2. Perform a manual capacitor re-formation.

3. Review the pulse generator’s current battery status. Counters should be

at zero. If the pulse generator battery status is not at BOL, do not implant

the pulse generator. Call Technical Services at the phone number provided

on the back of this manual.

Step C: Implant the Lead System

The pulse generator requires a lead system for sensing, pacing, and delivering

shocks. The pulse generator uses its case as a deﬁbrillating electrode.

Selection of lead conﬁguration and speciﬁc surgical procedures is a matter of

professional judgement. The following lead system conﬁgurations are available

for use with the pulse generator:

• ENDOTAK endocardial cardioversion/deﬁbrillation and pacing lead system

• Ventricular endocardial bipolar lead

• Atrial bipolar lead

• Unipolar sutureless myocardial leads and, if necessary, an appropriate

Guidant lead adapter

• Superior vena cava lead coupled with a ventricular patch lead

• Two-patch epicardial leads conﬁguration

CAUTION: The absence of a lead or plug in a lead port may affect device

performance. If a lead is not used, be sure to properly insert a plug in the

unused port.

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9-4 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

Whichever lead conﬁguration is used for both pacing/sensing and deﬁbrillating,

several considerations and cautions should be heeded. Such factors as

cardiomegaly or drug therapy may necessitate repositioning of the deﬁbrillating

leads or substituting one lead for another to facilitate arrhythmia conversion.

In some instances, no lead conﬁguration may be found that provides reliable

arrhythmia termination at energy levels available from the pulse generator;

implantation of the pulse generator is not recommended in these cases.

Implant the leads via the surgical approach chosen.

CAUTION: Do not suture directly over the lead body as this may cause

structural damage. Use the lead stabilizer to secure the lead lateral to the

venous entry side.

Step D: Take Baseline Measurements

Once the leads are implanted, take baseline measurements. Evaluate the

lead signals. If performing a pulse generator replacement procedure, existing

leads should be reevaluated, (e.g., signal amplitudes, pacing thresholds, and

impedance). The use of radiography may help ensure lead position and

integrity. If testing results are unsatisfactory, lead system repositioning or

replacement may be required.

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IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-5

• Connect the pace/sense lead(s) to a pacing system analyzer (PSA).

Pace/sense lead measurements, measured approximately 10 minutes

after placement, are listed below (Table 9-1 on page 9-5). Note that the

pulse generator measurements may not exactly correlate to the PSA

measurements due to signal ﬁltering.

Table 9-1. Lead measurements

Pace/sense lead

(acute)

Pace/sense lead

(chronic)

Shocking lead

(acute)

Shocking lead

(chronic)

R-wave amplitudeab > 5 mV > 5 mV > 1.0 mV > 1.0 mV

P-wave amplitudeab >1.5mV >1.5mV

R-wave durationbcd < 100 ms < 100 ms

Pacing threshold (right

ventricle)

<1.5V

endocardial

< 2.0 V epicardial

< 3.0 V endocardial

<3.5Vepicardial

Pacing threshold (atrium) <1.5V

endocardial

< 3.0 V endocardial

Lead impedance (at 5 V and

0.5 ms atrium and ventricle)

200–2000 Ω200–2000 Ω20–80 Ω20–80 Ω

a. Amplitudes less than 2 mV cause inaccurate rate counting in the chronic state, and result in inability to sense a tachyarrhythmia or

the misinterpretation of a normal rhythm as abnormal.

b. Lower R-wave amplitudes and longer duration may be associated with placement in ischemic or scarred tissues. Since signal

quality may deteriorate chronically, efforts should be made to meet the above criteria by repositioning the leads to obtain signals

with the largest possible amplitude and shortest duration.

c. Durations longer than 135 ms (the pulse generator’s refractory period) may result in inaccurate cardiac rate determination, inability

to sense a tachyarrhythmia, or in the misinterpretation of a normal rhythm as abnormal.

d. This measurement is not inclusive of current of injury.

Step E: Form the Implantation Pocket

Using standard operating procedures to prepare an implantation pocket,

choose the position of the pocket based on the implanted lead conﬁguration and

the patient’s body habitus. Giving consideration to patient anatomy and pulse

generator size and motion, gently coil any excess lead and place adjacent to

the pulse generator. It is important to place the lead into the pocket in a manner

that minimizes lead tension, twisting, sharp angles, and/or pressure. Pulse

generators are typically implanted subcutaneously in order to minimize tissue

trauma and facilitate explant. However, deeper implantation (e.g., subpectoral)

may help avoid erosion or extrusion in some patients. Verify magnet function

and wanded telemetry to ensure the pulse generator is within acceptable range.

Consider the following situations during the implant the procedure:

- DRAFT -

9-6 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

• If an abdominal implant is suitable, it is recommended that implantation

occur on the left abdominal side.

• Tunnel the leads if necessary. If a Guidant tunneler is not used, cap

the lead terminal pins, gently tunnel the leads subcutaneously to the

implantation pocket, and reevaluate the lead signals to determine if any of

the leads have been damaged during the tunneling procedure. A Penrose

drain, large chest tube, or tunneling tool may be used to tunnel the leads.

• If the lead terminal pins are not connected to a pulse generator at the time

of lead implantation, they must be capped before closing the incision.

Step F: Connect the Leads to the Pulse Generator

Lead connections are illustrated below.

– +

DF-1

IS-1

DF-1

Figure 9-1. Lead connections, single chamber

– +

RV RA

DF-1

IS-1

DF-1

IS-1

Figure 9-2. Lead connections, dual chamber

Setscrew locations are illustrated below.

Front of Pulse Generator

Defib (+)

Defib (-)

Suture Hole

RV (-)

Figure 9-3. Setscrew and suture hole locations, single chamber

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IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-7

Front of Pulse Generator

Defib (+)

Defib (-)

Suture Hole

RV (-)

RA (-)

Figure 9-4. Setscrew and suture hole locations, dual chamber

Lead to pulse generator connections

CAUTION: Do not insert a lead into the pulse generator connector without

ﬁrst visually verifying that the setscrew is sufﬁciently retracted to allow insertion.

Fully insert each lead into its lead port and then tighten the setscrew onto

the electrodes.

1. As each lead is inserted into the pulse generator, secure the lead in place

by tightening the setscrew with the torque wrench.

a. Insert the wrench into the center, preslit depression of the seal plug.

b. Place pressure on the lead to maintain its position in the pulse

generator lead port. Be certain that the lead remains fully inserted

intheleadport.

c. The large-handled torque wrench is preset to apply the proper amount

of force to the captive setscrew. Tighten the setscrew, making sure it is

not crooked, until the wrench ratchets; additional force is unnecessary.

d. Apply gentle traction to the leads to ensure a secure connection.

2. In models with IS-1 connectors, insert and secure the right ventricular

pace/sense lead terminal into the RV lead port.

NOTE: When connecting leads to a device header, connect the RV lead

ﬁrst. An RV lead is required to establish RV-based timing cycles that yield

appropriate sensing and pacing in all chambers, regardless of the programmed

conﬁguration.

- DRAFT -

9-8 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

3. In models with atrial connectors, insert and secure the atrial pace/sense

lead terminal into the A lead port.

4. In models with DF-1 connectors, insert the deﬁbrillating lead anode

(+, proximal) into the pulse generator’s (+) Deﬁb lead port. For proper

connection, be certain that the lead terminal pin is fully inserted in the pulse

generator lead port. When viewed through the side of the header, the pin

tip should extend through the terminal block.

5. Insert and secure the deﬁbrillating cathode (–, distal) in the (–) Deﬁblead

port in a similar manner as above.

CAUTION: For IS-1/DF-1 leads, never change the shock waveform

polarity by physically switching the lead anodes and cathodes in the pulse

generator header—use the programmable Polarity feature. Device damage

or nonconversion of the arrhythmia post-operatively may result if the polarity

is switched physically.

CAUTION: The absence of a lead or plug in a lead port may affect device

performance. If a lead is not used, be sure to properly insert a plug in the

unused port.

Consider the following lead connection information during the implant

procedure:

• The IS-1 pace/sense lead port(s) has one setscrew for securing the

terminal pin.

• The DF-1 port has one setscrew for securing the terminal pin.

• Avoid allowing blood or other body ﬂuids to enter the lead ports in the pulse

generator header. If ﬂuid inadvertently enters the ports, they should be

thoroughly cleaned using sterile water.

• To connect leads to the pulse generator, use only the tools provided in the

pulse generator tray or accessory kit to avoid damage to the seal plugs.

Failure to properly insert the wrench in the preslit depression of the seal

plug may result in damage to the plug and its sealing properties. Failure

to use the supplied torque wrench may result in damage to the screw or

connector threads. Do not implant the pulse generator if the seal plugs

appear to be damaged. Retain the tools until all testing procedures are

complete and the pulse generator is implanted.

- DRAFT -

IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-9

• If necessary, lubricate the lead connectors sparingly with sterile water to

make insertion easier.

• If a lead terminal encounters resistance on insertion into the lead port,

insert the wrench into the preslit depression of the seal plug and angle it

gently to open the valve and allow excess air to bleed out of the seal plug.

•Signiﬁcant amounts of ﬂuid or sterile water in a lead bore may make it

difﬁcult to fully insert leads. If signiﬁcant amounts of ﬂuid or sterile water

are present, insert the torque wrench into the setscrew before inserting the

leads. This will allow ﬂuid to drain from the lead bore.

• For proper connection of an IS-1 lead to the pulse generator, be certain that

the connector pin visibly extends through the connector block at least 1 mm.

Step G: Evaluate Lead Signals

1. Take the pulse generator out of power-saving Storage mode by

programming the Tachy Mode to Off.

CAUTION: To prevent inappropriate shocks, ensure that the pulse generator’s

Tachy Mode is programmed to Off when not in use and before handling the

device. For tachyarrhythmia therapy, verify that the Tachy Mode is activated.

2. Evaluate the pace/sense and deﬁbrillation lead signals by viewing the

real-time EGMs and markers. The signal from the implanted deﬁbrillation

leads should be continuous and without artifact, similar to a body-surface

ECG. A discontinuous signal may indicate a poor connection, lead fracture

or otherwise damaged lead, or an insulation break that would necessitate

lead replacement. Inadequate signals may result in failure of the pulse

generator system to detect an arrhythmia, inability to deliver programmed

therapy, or unnecessary delivery of therapy. Lead measurements should

reﬂect those in (Table 9-1 on page 9-5).

CAUTION: For dual-chamber models, take care to ensure that artifacts from

the ventricles are not present on the atrial channel, or atrial oversensing may

result. If ventricular artifacts are present in the atrial channel, the atrial lead

may need to be repositioned to minimize its interaction.

3. Evaluate all lead impedances using the Lead Impedance test accessed

from the Diagnostic Evaluation tool.

- DRAFT -

9-10 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

CAUTION: Never implant the device with a lead system that has less than

15 Ωtotal shock lead impedance. Device damage may result. If a shocking

lead impedance is less than 20 Ω, reposition the shocking electrodes to allow a

greater distance between the shocking electrodes.

Step H: Program the Pulse Generator

1. Check the programmer clock and set and synchronize the pulse generator

as necessary so that the proper time appears on printed reports and PRM

strip chart recordings.

2. It may be useful to program the Beep During Capacitor Charge feature to

On during conversion testing and implantation to help recognize when the

pulse generator is charging to deliver shock.

3. Perform a manual capacitor re-formation if not already performed.

4. Program the pulse generator to desired parameters appropriate for the

patient for necessary testing.

5. Shocks intended for VF therapy should be programmed with a 10 J safety

margin above the shock energy level that the physician determines is

required for successful VF conversion.

CAUTION: To prevent inappropriate shocks, ensure that the pulse generator’s

Tachy Mode is programmed to Off when not in use and before handling the

device. For tachyarrhythmia therapy, verify that the Tachy Mode is activated.

Step I: Implant the Pulse Generator

1. Program the Tachy Mode to Off.

2. Ensure that the pulse generator has good contact with surrounding tissue

of the implantation pocket. Suture hole locations are illustrated below.

Gently coil excess lead and place adjacent to the pulse generator. Flush

the pocket with saline solution, if necessary, to avoid a dry pocket.

WARNING: Kinking leads may cause additional stress on the leads,

possibly resulting in lead fracture.

CAUTION: Improper insertion can cause insulation damage near the

terminal end that could result in lead failure.

- DRAFT -

IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR 9-11

Front of Pulse Generator

Defib (+)

Defib (-)

Suture Hole

RV (-)

Figure 9-5. Setscrew and suture hole locations, single chamber

Front of Pulse Generator

Defib (+)

Defib (-)

Suture Hole

RV (-)

RA (-)

Figure 9-6. Setscrew and suture hole locations, dual chamber

3. Close the implantation pocket. Consideration should be given to place

the leads in a manner to prevent contact with suture materials. It is

recommended that absorbable sutures be used for closure of tissue layers.

4. Complete any electrocautery procedures before reactivating the pulse

generator.

5. Program the Tachy Mode to the desired setting and conﬁrm ﬁnal

programmed parameters.

6. Print out parameter reports and save all data to disk using the programmer’s

Save to Disk option.

Step J: Complete and Return the Implantation Form

Within ten days of implantation, complete the Warranty Validation and Lead

Registration form and return the original to Boston Scientiﬁcalongwithacopy

of the patient data disk. This information enables Boston Scientiﬁctoregister

each implanted pulse generator and set of leads, initiate the warranty period,

- DRAFT -

9-12 IMPLANT INFORMATION

IMPLANTING THE PULSE GENERATOR

and provide clinical data on the performance of the implanted system. Keep a

copy of the Warranty Validation and Lead Registration form and programmer

printouts, and the original patient data disk for the patient’s ﬁle.

Complete the temporary patient identiﬁcation card and give it to the patient.

After receiving the validation form, Boston Scientiﬁc sends the patient a

permanent identiﬁcation card.

NOTE: A registration form is packaged with each pulse generator lead. If

completing the pulse generator Warranty Validation and Lead Registration

form for the pulse generator, completing separate validation forms for each

lead is not necessary.

- DRAFT -

10-1

POST IMPLANT INFORMATION

CHAPTER 10

This chapter contains the following topics:

• "Follow Up Testing" on page 10-2

• "Post Implant features" on page 10-3

• "Explantation" on page 10-8

- DRAFT -

10-2 POST IMPLANT INFORMATION

FOLLOW UP TESTING

It is recommended that device functions be evaluated during follow-up testing.

WARNING: Ensure that an external deﬁbrillator and medical personnel skilled

in CPR are present during post-implant device testing should the patient

require external rescue.

Predischarge Follow Up

During the pre-discharge follow-up test, the following procedures should be

performed via telemetry using the PRM:

1. Interrogate the pulse generator and review the Summary screen.

2. Perform pacing thresholds and lead impedance tests, and intrinsic

amplitude measurements.

3. Review Histograms.

4. When all testing is complete, perform a ﬁnal interrogation and save all the

data to a patient data disk.

5. Print the Quick Notes and Patient Data reports to retain in your ﬁles for

future reference.

6. It is important to clear the therapy counters so that at the next follow-up

session the most recent episode data will be displayed. Note that the

histogram counters can be cleared from either the Brady or Tachy Counters

screen as well.

Routine Follow Up

You should conduct routine follow-up examinations one month after the

pre-discharge study and every three months thereafter. During the routine

follow-up test, the following procedures should be performed via telemetry

using the programming system:

1. Interrogate the device and review the Summary screen.

2. Perform pacing thresholds and lead impedance tests, and intrinsic

amplitude measurements.

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POST IMPLANT INFORMATION

POST IMPLANT FEATURES 10-3

3. Print and review the Quick Notes report, and retain it in your ﬁles for future

reference.

4. For episodes of interest, review the Arrhythmia Logbook screen and print

episode details and stored electrogram information.

5. It is important to clear the therapy counters so that at the next follow-up

session the most recent episode data will be displayed.

CAUTION: Verify with a conversion test that the patient’s tachyarrhythmias

can be detected and terminated by the pulse generator system if the patient’s

status has changed or parameters have been reprogrammed.

POST IMPLANT FEATURES

Sensitivity Adjustment

The Sensitivity Adjustment feature allows you to shift the atrial sensing range to

make it less sensitive (i.e., a larger signal would be required for the device to

detect). It allows shifting the ventricular sensing range to make it less or more

sensitive. While the Nominal setting is primarily indicated for both atrial and

ventricular sensing, an adjustment can be made if, in a rare situation, atrial or

ventricular oversensing/undersensing has been observed post-implant (i.e.,

inhibition of bradycardia pacing or inappropriate tachy therapy).

Should it become necessary to adjust the sensing range in a chamber,

always choose the setting that allows the greatest sensitivity, but resolves

oversensing/undersensing:

• To reduce oversensing, program the sensitivity to a higher value.

• To reduce undersensing, program the sensitivity to a lower value.

After any change to sensitivity, evaluate for appropriate sensing for both

bradycardia pacing and tachycardia detection.

If proper sensing cannot be restored with an adjustment or if any undersensing

is observed after making a change, consider repositioning the lead or implanting

a new sensing lead and then programming the setting back to nominal.

CAUTION: Following any sensing range adjustment or any modiﬁcation of

the sensing lead, always verify appropriate sensing.

- DRAFT -

10-4 POST IMPLANT INFORMATION

POST IMPLANT FEATURES

Beeper Feature

The pulse generator contains a beeper that emits audible tones to

communicate status information. The beeper includes both programmable and

nonprogrammable features.

Programmable Features

The following beeper features are programmable:

• Beep During Capacitor Charge—When programmed to On, regardless of

the Tachy mode, a warbling tone will sound continuously while the pulse

generator is charging (except when charging during an auto capacitor

re-form). The tone will continue until charging is complete. When this

feature is programmed to Off, there is no audible indication that the pulse

generator is charging. This feature is useful during EP testing.

• Beep When Explant Is Indicated—When this feature is programmed to

On, the pulse generator emits tones upon reaching Explant. The Explant

indicator consists of 16 tones repeated every six hours after the pulse

generator reaches Explant until the feature is turned off via the programmer.

When this feature is programmed to Off, there is no audible indication

of Explant.

Perform the following steps to program the magnet and beeper features:

Magnet and Beeper Response

1. Select the Settings tab.

2. From Ventricular Tachy, select the Therapy button.

3. Select the V-Tachy Therapy Setup button.

4. Enter the desired values.

Beep when Explant is indicated

1. Select the Summary tab.

2. Select the Battery button.

3. From the Battery Status summary screen, select the Battery Detail button.

- DRAFT -

POST IMPLANT INFORMATION

POST IMPLANT FEATURES 10-5

4. From the Battery Detail summary screen, select the desired value for Beep

when Explant is indicated.

NOTE: When the Magnet Response is programmed to Inhibit Therapy,

magnet application will cause other types of beeping tones to be emitted,

depending on the device mode. Refer to "Magnet Feature" on page 10-5 for

more information.

Nonprogrammable Features

The following beeper features are nonprogrammable:

• Battery capacity depleted—Regardless of whether Beep When Explant

Is Indicated is programmed to On or Off, once the battery capacity is

depleted, the pulse generator will emit the explant indicator tones

• Fault code tones—For certain fault codes or when safety mode is entered,

the pulse generator will beep 16 times every 6 hours.

NOTE: Beeping tones may emit under nonprogrammable scenarios in

response to device self-diagnostic testing. Advise patients to have their

pulse generator checked whenever they hear tones coming from the device.

Contact Technical Services at the phone number on the back of this manual

for assistance.

Magnet Feature

The magnet feature allows certain device functions to be triggered when a

magnet is placed in close proximity to the pulse generator (Figure 10-1 on

page 10-6).

- DRAFT -

10-6 POST IMPLANT INFORMATION

POST IMPLANT FEATURES

Position the magnet over the

pulse generator as shown.

Magnet (model 6860)

3.0 cm

Pulse generator

Top View

Figure 10-1. Proper position of magnet Model 6860 to activate the pulse generator magnet feature

The pulse generator Magnet Response settings can be programmed to control

the behavior of the pulse generator when a magnet is detected. The Magnet

Response settings are located in the Magnet and Beeper section of the V-Tachy

Therapy Setup screen. The following Magnet Response settings are available:

• Off—no response

• Store EGM—patient monitoring data will be stored

• Inhibit Therapy—therapy will be stopped

Off

When the Magnet Response is programmed to Off, application of the magnet

will have no effect on the pulse generator.

Store EGM

When the Magnet Response is programmed to Store EGM, application of the

magnet will activate the patient triggered monitor functionality. Refer to "Patient

Triggered Monitor" on page 7-13 for additional information.

Inhibit Therapy

- DRAFT -

POST IMPLANT INFORMATION

POST IMPLANT FEATURES 10-7

When the Magnet Response is programmed to Inhibit Therapy, application of

the magnet will inhibit and/or divert charging for a shock, divert a shock that is

about to be delivered, or inhibit and/or divert further ATP therapy.

When Magnet Response is programmed to Inhibit Therapy, initiation of

tachyarrhythmia therapy and arrhythmia induction is inhibited any time the

magnet is properly positioned over the pulse generator. The tachyarrhythmia

detection process continues, but therapy or induction cannot be triggered.

When a magnet is placed over the pulse generator, the following will occur:

• If the Tachy mode is Monitor + Therapy or Off when the magnet is applied,

the Tachy mode changes temporarily to Monitor Only mode and will

remain in Monitor Only mode as long as the magnet is applied. Three

seconds after the magnet is removed, the mode will return to the previously

programmed mode.

• If the pulse generator is charging to deliver shock therapy when the magnet

is applied, the charging continues but is then terminated within one to two

seconds of magnet application, and the charge is diverted. (This delay

occurs in case the magnet is inadvertently passed over the device when

therapy inhibition is not desired.) The pulse generator remains in temporary

Monitor Only mode while the magnet is applied. No further therapy is

initiated until the magnet is removed; however, detection will continue.

• If charging is complete or completes within the 1–2 second delay period,

holding the magnet over the pulse generator for more than two seconds

will divert the shock. (If the magnet is removed during the delay period,

the shock could still be delivered.) Shocks will not be delivered with the

magnet in place.

• If the pulse generator is initiating ﬁbrillation induction or ATP pulses, it

terminates the delivery after one to two seconds of magnet application. No

further induction or ATP pulse sequences are initiated until the magnet

is removed.

• If the Tachy Mode is Monitor Only or Off, magnet application will produce a

constant tone to indicate that the device is in a non-therapy mode.

• If the Tachy Mode is Monitor + Therapy or the pulse generator is in

Electrocautery Protection Mode, magnet application will cause the pulse

generator to beep once per second to indicate that the device is in a

therapy mode.

- DRAFT -

10-8 POST IMPLANT INFORMATION

EXPLANTATION

NOTE: If tachy detection occurs while the magnet is in place, detailed therapy

history will indicate that therapy was not delivered because the device was

in Monitor Only mode.

EXPLANTATION

An Observation/Complication/Out-of-Service Reporting form should be

completed and sent to Boston Scientiﬁc when a product is removed from

service. Return all explanted pulse generators and leads with product

performance allegations or warranty considerations to Boston Scientiﬁc.

Examination of explanted devices provides information for continued

improvement in device reliability and will permit calculation of any warranty

replacement credit use.

In the event of patient death (regardless of cause), the explanted pulse

generator and/or lead should be returned to Boston Scientiﬁcalong

with the Observation/Complication/Out-of-Service Reporting form and

copies of the autopsy report, if performed. For other observation or

complications reasons, also complete and return to Boston Scientiﬁcthe

Observation/Complication/Out-of-Service Reporting form.

NOTE: Disposal of explanted devices is subject to local, state, and federal

regulations. Contact your sales representative or call the phone number on the

back cover of this manual for a Returned Product Kit.

NOTE: Discoloration of the pulse generator may have occurred due to a

normal process of anodization, and has no effect on the pulse generator

function.

CAUTION: Be sure that the pulse generator is removed before cremation.

Cremation and incineration temperatures might cause the pulse generator to

explode.

CAUTION: Before explanting, cleaning, or shipping the device, complete the

following actions to prevent unwanted shocks, overwriting of important therapy

history data, and audible tones:

• Program the pulse generator Tachy and Brady Modes to Off.

• Program the Magnet Response feature to Off.

• Program the Beep When Explant is Indicated feature to Off.

Consider the following items when explanting and returning the pulse generator:

- DRAFT -

POST IMPLANT INFORMATION

EXPLANTATION 10-9

• Interrogate the pulse generator and print a Combined Follow-up report.

• Deactivate the pulse generator before explantation.

• Disconnect the leads from the pulse generator.

• If leads are also explanted, attempt to remove them intact. Do not remove

leads with hemostats or any other clamping tool that may damage the

leads. Resort to tools only if manual manipulation cannot free the lead.

• Wash, but do not submerge, the pulse generator and leads to remove

body ﬂuids and debris using a disinfectant solution. Do not allow ﬂuids to

enter the pulse generator’s lead ports.

• UseaBostonScientiﬁc Returned Product Kit to properly package the

pulse generator.

• Complete the Observation/Complication/Out-of-Service Reporting form.

• Send the form and the Returned Product Kit to Boston Scientiﬁc.

- DRAFT -

10-10 POST IMPLANT INFORMATION

EXPLANTATION

- DRAFT -

A-1

PROGRAMMABLE OPTIONS

APPENDIX A

Table A-1. ZIP Telemetry settings

Parameter Programmable Values Nominal

Communication Mode Enable use of ZIP telemetry (May

require limited use of wand), Use

wand for all telemetry

Enable use of ZIP telemetry (May

require limited use of wand)

Table A-2. Tachy Mode parameter

Parameter Programmable Values Nominal

Tachy Mode Off, Monitor Only, Monitor + Therapy,

Enable Electrocautery Protection

Storage

Table A-3. Ventricular Zones parameter

Parameter Programmable Values Nominal

Ventricular Zones 1, 2, 3 2

Table A-4. Detection parameters for 1-zone, 2-zone, and 3-zone conﬁgurations

Parameter VT-1 Zone VT Zone VF Zone Nominal

Ratea( bpm) 3 zones

(intervals in ms)

90, 95, ..., 200

(667–300)

110, 115, ..., 210

(545–286) 220 (273)

130, 135, ..., 210

(462–286), 220, 230,

240, 250 (273–240)

140 (Tolerance ± 5

ms) for VT-1 Zone

160 (Tolerance ± 5

ms) for VT Zone

200 (Tolerance ± 5

ms) for VF Zone

Ratea( bpm) 2 zones

(intervals in ms)

–– 90, 95, ..., 210

(667–286) 220 (273)

110, 115, ..., 210

(545–286) 220, 230,

240, 250 (273–240)

160 (Tolerance ± 5

ms) for VT Zone

200 (Tolerance ± 5

ms) for VF Zone

Ratea( bpm) 1 zone

(intervals in ms)

–– –– 90, 95, ..., 210 (667–

286) 220 (273)

200 (Tolerance ± 5

ms)

Initial Durationb

(sec) 3 zones

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, ..., 60.0

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, 30.0

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

2.5 (Tolerance ± 1

cardiac cycle) for

VT-1 Zone

2.5 (Tolerance ± 1

cardiac cycle) for VT

Zone

1.0 (Tolerance ± 1

cardiac cycle) for VF

Zone

- DRAFT -

A-2 PROGRAMMABLE OPTIONS

Table A-4. Detection parameters for 1-zone, 2-zone, and 3-zone conﬁgurations (continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Initial Durationb

(sec) 2 zones

–– 1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, 30.0

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

2.5 (Tolerance ± 1

cardiac cycle) for VT

Zone

1.0 (Tolerance ± 1

cardiac cycle) for VF

Zone

Initial Durationb

(sec) 1 zone

–– –– 1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

1.0 (Tolerance ± 1

cardiac cycle)

Redetection

Durationb(sec) 3

zones

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle) for all

zones

Redetection

Durationb(sec) 2

zones

–– 1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0

1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle) for all

zones

Redetection

Durationb(sec) 1

zone

–– –– 1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle)

Post-shock

Durationb(sec) 3

zones

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, ..., 60.0

1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, 30.0

1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle) for all

zones

Post-shock

Durationb(sec) 2

zones

–– 1.0, 1.5, ..., 5.0, 6.0,

7.0, ..., 15.0, 20.0,

25.0, 30.0

1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle) for all

zones

Post-shock

Durationb(sec) 1

zone

–– –– 1.0

(nonprogrammable)

1.0 (Tolerance ± 1

cardiac cycle)

a. The Rate difference between each tachy zone must be at least 20 bpm. The lowest Tachy Rate Threshold must be ≥5 bpm

higher than the Maximum Tracking Rate, Maximum Sensor Rate, and the Maximum Pacing Rate; and the lowest Tachy Rate

Threshold must be ≥15 bpm higher than the Lower Rate Limit.

b. The Duration in a zone must be equal to or greater than the Duration in the next highest zone.

Table A-5. Ventricular Detection Enhancement Type for 2-zone and 3-zone conﬁgurations

Parameter Programmable Values Nominal

Detection Enhancement Type Off, Rhythm ID, Onset/Stability Rhythm ID

Table A-6. Onset/Stability detection enhancement parameters for 2-zone and 3-zone conﬁgurations

Parameter VT-1 Zone VT Zone VF Zone Nominal

V Rate > A Rate 3

zones

Off, On –– –– On

V Rate > A Rate 2

zones

–– Off, On –– On

- DRAFT -

PROGRAMMABLE OPTIONS A-3

Table A-6. Onset/Stability detection enhancement parameters for 2-zone and 3-zone conﬁgurations

(continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

AFib Rate Threshold

( bpm) 3 zones

Off, 100, 110, ..., 300 –– –– 170 (Tolerance ± 5

ms)

AFib Rate Threshold

( bpm) 2 zones

–– Off, 100, 110, ..., 300 –– 170 (Tolerance ± 5

ms)

Stability (ms) 3

zones

Off, 6, 8, ..., 32 35,

40, ..., 60 70, 80, ...,

120

–– –– 20 (DR); 30 (VR)

(Tolerance ± 5 ms)

Stability (ms) 2

zones

–– Off, 6, 8, ..., 32 35,

40, ..., 60 70, 80, ...,

120

–– 20 (DR); 30 (VR)

(Tolerance ± 5 ms)

Shock If Unstable

(ms) 3 zones

–– Off, 6, 8, ..., 32 35,

40, ..., 60 70, 80, ...,

120

–– 30 (Tolerance ± 5

ms)

Shock If Unstable

(ms) 2 zones

–– Off, 6, 8, ..., 32 35,

40, ..., 60 70, 80, ...,

120

–– Off (Tolerance ± 5

ms)

Onset (% or ms) 3

zones

Off, 9, 12, 16, 19, ...,

37 41, 44, 47, 50%

or 50, 60, ..., 250 ms

–– –– 9% (Tolerance ± 5

ms)

Onset (% or ms) 2

zones

–– Off, 9, 12, 16, 19, ...,

37, 41, 44, 47, 50%

or 50, 60, ..., 250 ms

–– 9% (Tolerance ± 5

ms)

Stability And/Or

Onset 3 zones

And, Or –– –– And

Stability And/Or

Onset 2 zones

–– And, Or –– And

Sustained Rate

Duration (min:sec) 3

zones

Off, 00:10, 00:15, ...,

00:55 01:00, 01:15,

..., 02:00 02:30,

03:00, ..., 10:00

15:00, 20:00, ...,

60:00

–– –– 03:00 (Tolerance ± 1

cardiac cycle)

Sustained Rate

Duration (min:sec) 2

zones

–– Off, 00:10, 00:15, ...,

00:55 01:00, 01:15,

..., 02:00 02:30,

03:00, ..., 10:00

15:00, 20:00, ...,

60:00

–– 03:00 (Tolerance ± 1

cardiac cycle)

Detection

Enhancement 3

zones

Off, On Off, On –– On (VT-1) Off (VT)

- DRAFT -

A-4 PROGRAMMABLE OPTIONS

Table A-6. Onset/Stability detection enhancement parameters for 2-zone and 3-zone conﬁgurations

(continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Detection

Enhancement 2

zones

–– Off, On –– On

Atrial

Tachyarrhythmia

Discrimination 3

zones

Off, On –– –– On

Atrial

Tachyarrhythmia

Discrimination 2

zones

–– Off, On –– On

Sinus Tachycardia

Discrimination 3

zones

Off, On –– –– On

Sinus Tachycardia

Discrimination 2

zones

–– Off, On –– On

Polymorphic VT

Discrimination 3

zones

–– Off, On –– On

Polymorphic VT

Discrimination 2

zones

–– Off, On –– Off

Table A-7. Rhythm ID detection enhancement parameters for 2-zone and 3-zone conﬁgurations

Parameter VT-1 Zone VT Zone VF Zone Nominal

Detection

Enhancement 3

zones

Off, On Off, On –– On (VT-1) Off (VT)

Detection

Enhancement 2

zones

–– Off, On –– On

Sustained Rate

Duration (min:sec) 3

zones

Off, 00:10, 00:15,

..., 01:00, 01:15,

..., 02:00, 02:30,

..., 10:00, 15:00, ...,

60:00

Off, 00:10, 00:15,

..., 01:00, 01:15,

..., 02:00, 02:30,

..., 10:00, 15:00, ...,

60:00

–– 03:00 (VT-1 and

VT) (Tolerance ± 1

cardiac cycle)

Sustained Rate

Duration (min:sec) 2

zones

–– Off, 00:10, 00:15,

..., 01:00, 01:15,

..., 02:00, 02:30,

..., 10:00, 15:00, ...,

60:00

–– 03:00 (Tolerance ± 1

cardiac cycle)

- DRAFT -

PROGRAMMABLE OPTIONS A-5

Table A-7. Rhythm ID detection enhancement parameters for 2-zone and 3-zone conﬁgurations (continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Passive Method 3

zones (one value for

all zones)

Off, On Off, On –– On

Passive Method 2

zones (one value for

all zones)

–– Off, On –– On

Active Method 3

zones (one value for

all zones)

Off, On Off, On –– On

Active Method 2

zones (one value for

all zones)

–– Off, On –– On

Temp LRL ( ppm)

(one value for all

zones)

Use Norm LRL, 30,

35, ..., 105

Use Norm LRL, 30,

35, ..., 105

–– Use Norm LRL

(Tolerance ± 5 ms)

Temp LRL 2 zones

( ppm) (one value for

all zones)

–– Use Norm LRL, 30,

35, ..., 105

–– Use Norm LRL

(Tolerance ± 5 ms)

Atrial Tachy

Discrimination 3

zones (one value for

all zones)

Off, On Off, On –– On

Atrial Tachy

Discrimination 2

zones (one value for

all zones)

–– Off, On –– On

AFib Rate Threshold

( bpm) 3 zones (one

value for all zones)

100, 110, ..., 300 100, 110, ..., 300 –– 170 (Tolerance ± 5

ms)

AFib Rate Threshold

( bpm) 2 zones (one

value for all zones)

–– 100, 110, ..., 300 –– 170 (Tolerance ± 5

ms)

Stability (ms) 3

zonesa(one value

for all zones)

6, 8, ..., 32, 35, 40,

..., 60, 70, ..., 120

6, 8, ..., 32, 35, 40,

..., 60, 70, ..., 120

–– 20 (DR); 30 (VR)

(Tolerance ± 5 ms)

Stability (ms) 2

zonesa(one value

for all zones)

–– 6, 8, ..., 32, 35, 40,

..., 60, 70, ..., 120

–– 20 (DR); 30 (VR)

(Tolerance ± 5 ms)

a. The Stability parameter only applies in Post-shock for VR devices.

- DRAFT -

A-6 PROGRAMMABLE OPTIONS

Table A-8. Post-shock Onset/Stability detection enhancement parameters for 2-zone and 3-zone

conﬁgurations

Parameter VT-1 Zone VT Zone VF Zone Nominal

Post-shock V Rate >

A Rate 3 zones

Off, On –– –– On

Post-shock V Rate >

A Rate 2 zones

–– Off, On –– On

Post-shock AFib

Rate Threshold

( bpm) 3 zones

Off, 100, 110, ..., 300 –– –– 170 (Tolerance ± 5

ms)

Post-shock AFib

Rate Threshold

( bpm) 2 zones

–– Off, 100, 110, ..., 300 –– 170 (Tolerance ± 5

ms)

Post-shock Stability

(ms) 3 zones

Off, 6, 8, ..., 32, 35,

40, ..., 60, 70, 80, ...,

120

–– –– 20 (DR); 30 (VR)

(Tolerance ± 5 ms)

Post-shock Stability

(ms) 2 zones

–– Off, 6, 8, ..., 32, 35,

40, ..., 60, 70, 80, ...,

120

–– 20 (DR); 30 (VR)

(Tolerance ± 5 ms)

Post-shock

Sustained Rate

Duration (min:sec) 3

zones

Off, 00:10, 00:15, ...,

00:55, 01:00, 01:15,

..., 02:00, 02:30,

03:00, ..., 10:00,

15:00, 20:00, ...,

60:00

–– –– 00:15 (Tolerance ± 1

cardiac cycle)

Post-shock

Sustained Rate

Duration (min:sec) 2

zones

–– Off, 00:10, 00:15, ...,

00:55, 01:00, 01:15,

..., 02:00, 02:30,

03:00, ..., 10:00,

15:00, 20:00, ...,

60:00

–– 00:15 (Tolerance ± 1

cardiac cycle)

Table A-9. Post-shock Rhythm ID detection enhancement parameters for 2-zone and 3-zone conﬁgurations

Parameter VT-1 Zone VT Zone VF Zone Nominal

Post-shock

Detection

Enhancement 3

zones

Off, On Off, On –– Off

Post-shock

Detection

Enhancement 2

zones

–– Off, On –– Off

- DRAFT -

PROGRAMMABLE OPTIONS A-7

Table A-9. Post-shock Rhythm ID detection enhancement parameters for 2-zone and 3-zone conﬁgurations

(continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Post-shock

Sustained Rate

Duration (min:sec) 3

zones

Off, 00:10, 00:15,

01:00, 01:15, ...,

02:00, 02:30, ...,

10:00, 15:00, ...,

60:00

Off, 00:10, 00:15,

01:00, 01:15, ...,

02:00, 02:30, ...,

10:00, 15:00, ...,

60:00

–– 0:15 (Tolerance ± 1

cardiac cycle)

Post-shock

Sustained Rate

Duration (min:sec) 2

zones

–– Off, 00:10, 00:15,

01:00, 01:15, ...,

02:00, 02:30, ...,

10:00, 15:00, ...,

60:00

–– 0:15 (Tolerance ± 1

cardiac cycle)

Table A-10. Ventricular ATP parameters (speciﬁed into a 750 Ωload)

Parameter VT-1 Zone VT Zone VF Zone Nominal

ATP Type 3 zones Off, Burst, Ramp,

Scan, Ramp/Scan

Off, Burst, Ramp,

Scan, Ramp/Scan

–– Off (VT-1); Burst (VT

ATP1); Ramp (VT

ATP2)

ATP Type 2 zones –– Off, Burst, Ramp,

Scan, Ramp/Scan

–– Burst (VT ATP1);

Ramp (VT ATP2)

Number of Bursts

(per scheme) 3

zones

Off, 1, 2, ..., 30 Off, 1, 2, ..., 30 –– Off (VT-1); 2 (VT

ATP1); 1 (VT ATP2)

Number of Bursts

(per scheme) 2

zones

–– Off, 1, 2, ..., 30 –– 2 (VT ATP1); 1 (VT

ATP2)

Initial Pulse (pulses)

3 zones

1, 2, ..., 30 1, 2, ..., 30 –– 4 (VT-1); 10 (VT)

Initial Pulse (pulses)

2 zones

–– 1, 2, ..., 30 –– 10

Pulse Increment

(pulses) 3 zones

0, 1, ..., 5 0, 1, ..., 5 –– 0

Pulse Increment

(pulses) 2 zones

–– 0, 1, ..., 5 –– 0

Maximum Number

of Pulses 3 zones

1, 2, ..., 30 1, 2, ..., 30 –– 4 (VT-1); 10 (VT)

Maximum Number

of Pulses 2 zones

–– 1, 2, ..., 30 –– 10

Coupling Interval (%

or ms) 3 zones

50, 53, 56, 59; 63,

66, ..., 84, 88, 91,

94, 97% or 120, 130,

..., 750 ms

50, 53, 56, 59; 63,

66,...,84,88,91,

94, 97% or 120, 130,

..., 750 ms

–– 81% (Tolerance ± 5

ms)

- DRAFT -

A-8 PROGRAMMABLE OPTIONS

Table A-10. Ventricular ATP parameters (speciﬁed into a 750 Ωload) (continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Coupling Interval (%

or ms) 2 zones

–– 50, 53, 56, 59; 63,

66,...,84,88,91,

94, 97% or 120, 130,

..., 750 ms

–– 81% (Tolerance ± 5

ms)

Coupling Interval

Decrement (ms) 3

zones

0, 2, ..., 30 0, 2, ..., 30 –– 0(Tolerance±5ms)

Coupling Interval

Decrement (ms) 2

zones

–– 0, 2, ..., 30 –– 0(Tolerance±5ms)

Burst Cycle Length

(BCL) (% or ms) 3

zones

50, 53, 56, 59; 63,

66, ..., 84, 88, 91,

94, 97% or 120, 130,

..., 750 ms

50, 53, 56, 59; 63,

66,...,84,88,91,

94, 97% or 120, 130,

..., 750 ms

–– 81% (Tolerance ± 5

ms)

Burst Cycle Length

(BCL) (% or ms) 2

zones

–– 50, 53, 56, 59; 63,

66,...,84,88,91,

94, 97% or 120, 130,

..., 750 ms

–– 81% (Tolerance ± 5

ms)

Ramp Decrement

(ms) 3 zones

0, 2, ..., 30 0, 2, ..., 30 –– 0(VT-1);0(VT

ATP1); 10 (VT ATP2)

(Tolerance ± 5 ms)

Ramp Decrement

(ms) 2 zones

–– 0, 2, ..., 30 –– 0 (VT ATP1); 10 (VT

ATP2) (Tolerance ±

5ms)

Scan Decrement

(ms) 3 zones

0, 2, ..., 30 0, 2, ..., 30 –– 0(Tolerance±5ms)

Scan Decrement

(ms) 2 zones

–– 0, 2, ..., 30 –– 0(Tolerance±5ms)

Minimum Interval

(ms) 3 zones

120, 130, ..., 400 120, 130, ..., 400 –– 220 (Tolerance ± 5

ms)

Minimum Interval

(ms) 2 zones

–– 120, 130, ..., 400 –– 220 (Tolerance ± 5

ms)

Right Ventricular

ATP Pulse Widtha

(ms) 3 zones (one

value for all zones)

0.1, 0.2, ..., 2.0 0.1, 0.2, ..., 2.0 –– 1.0(Tolerance±

0.03 ms at < 1.8 ms;

±0.08msat≥1.8

ms)

Right Ventricular

ATP Pulse Widtha

(ms) 2 zones (one

value for all zones)

–– 0.1, 0.2, ..., 2.0 –– 1.0(Tolerance±

0.03 ms at < 1.8 ms;

±0.08msat≥1.8

ms)

- DRAFT -

PROGRAMMABLE OPTIONS A-9

Table A-10. Ventricular ATP parameters (speciﬁed into a 750 Ωload) (continued)

Parameter VT-1 Zone VT Zone VF Zone Nominal

Right Ventricular

ATP Amplitudea(V)

3 zones (one value

for all zones)

0.1, 0.2, ..., 3.5, 4.0,

..., 7.5

0.1, 0.2, ..., 3.5, 4.0,

..., 7.5

–– 5.0(Tolerance±

15% or ± 100 mV,

whichever is greater)

Right Ventricular

ATP Amplitudea(V)

2 zones (one value

for all zones)

–– 0.1, 0.2, ..., 3.5, 4.0,

..., 7.5

–– 5.0(Tolerance±

15% or ± 100 mV,

whichever is greater)

ATP Time-outb

(seconds) 3 zones

Off, 10, 15, ..., 60,

75, 90, ..., 120, 150,

..., 600, 900, ...,

3600

Off, 10, 15, ..., 60,

75, 90, ..., 120, 150,

..., 600, 900, ...,

3600

–– 60 (Tolerance ± 1

cardiac cycle)

ATP Time-outb

(seconds) 2 zones

–– Off, 10, 15, ..., 60,

75, 90, ..., 120, 150,

..., 600, 900, ...,

3600

–– 60 (Tolerance ± 1

cardiac cycle)

QUICK CONVERT

ATP (VF Only) 3

zones

–– –– Off, On On

QUICK CONVERT

ATP (VF Only) 2

zones

–– –– Off, On On

a. The programmed Amplitude and Pulse Width values affect Post Therapy Brady Pacing, but are separately programmable from

Normal Brady Pacing, Temporary Brady Pacing, and EP Test.

b. The VT-1 ATP Time-out must be greater than or equal to the VT ATP Time-out.

Table A-11. Ventricular Shock Parameters

Parameter Programmable Values Nominal

Shocks 1 and 2 energy (J)abc

(stored energy)

Off, 0.1, 0.3, 0.6, 0.9, 1.1, 1.7, 2, 3,

5, 6, 7, 9, 11, 14, 17, 21, 23, 26, 29,

31, 36 (HE), 41 (HE)

41 J (Tolerance ± 60% for ≤0.3 J, ±

40% for ≤0.6–3 J, ± 20% for 5–36

J, ± 10% for 41 J)

Energy of Remaining Shocks (J)ac

(stored energy)

Off, 41 (HE) 41 J (Tolerance ± 10% for 41 J)

Lead PolaritydInitial, Reversed Initial

Committed Shock Off, On Off

Shock Lead Vector RV Coil to RA Coil and Can, RV Coil

to Can, RV Coil to RA Coil

RV Coil to RA Coil and Can

a. Biphasic energy is speciﬁed.

b. The Shock 2 energy level must be greater than or equal to the Shock 1 energy level.

c. In a VT-1 zone of a 3-zone conﬁguration or a VT zone of a 2-zone conﬁguration, all or some of the shocks may be programmed to

Off while other shocks in that zone are programmed in joules.

d. A commanded STAT SHOCK is delivered at the programmed Polarity.

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A-10 PROGRAMMABLE OPTIONS

Table A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (speciﬁed into a 750 Ωload)

Parameter Programmable Values Nominal

Modeabgk DDD(R), DDI(R), VDD(R), VVI(R),

AAI(R), Off; Temporary: DDD, DDI,

DOO, VDD, VVI, VOO, AAI, AOO,

Off

DDD (DR); VVI (VR)

Lower Rate Limit (LRL)ac( ppm) 30, 35, ..., 185 60 (Tolerance ± 5 ms)

Maximum Tracking Rate (MTR) gj

( ppm)

30, 35, ..., 185 130(Tolerance±5ms)

Maximum Sensor Rate (MSR)gj

( ppm)

30, 35, ..., 185 130(Tolerance±5ms)

Pulse Amplitudeadef(atrium) (V) 0.1, 0.2, ... 3.5, 4.0, ..., 5.0 3.5 (5.0 post-therapy) (Tolerance

± 15% or ± 100mV, whichever is

greater)

Pulse Amplitudeadef(right ventricle)

(V)

0.1, 0.2, ..., 3.5, 4.0, ..., 7.5 3.5 (5.0 post-therapy) (Tolerance

± 15% or ± 100mV, whichever is

greater)

Pulse Widthadef(atrium, right

ventricle) (ms)

0.1, 0.2, ..., 2.0 0.4 (1.0 post-therapy) (Tolerance ±

0.03 ms at < 1.8 ms; ± 0.08 ms at

≥1.8 ms)

Atrial Pace/Sense Conﬁgurationag Bipolar, Off Bipolar

Activity Thresholdgj Very High, High, Medium High,

Medium, Medium Low, Low, Very

Low

Medium

Reaction Timegj(sec) 10, 20, ..., 50 30

Response Factorgj 1, 2, ..., 16 8

Recovery Timegj(min) 2, 3, ..., 16 2

Maximum PVARPag(ms) 150, 160, ..., 500 280(Tolerance±5ms)

Minimum PVARPag(ms) 150, 160, ..., 500 240(Tolerance±5ms)

PVARP After PVCag(ms) Off, 150, 200, ..., 500 400 (Tolerance ± 5 ms)

V-Blank After A-Paceah(ms) 45, 65, 85, Smart Smart (Tolerance ± 5 ms)

A-Blank After V-Paceah(ms) 45, 65, 85, Smart Smart (Tolerance ± 5 ms)

A-Blank After V-Senseah(ms) 45, 65, 85, Smart Smart (Tolerance ± 5 ms)

Maximum VRP (right ventricle)ai

(ms)

150, 160, 170, ..., 500 250(Tolerance±5ms)

Minimum VRP (right ventricle)ai

(ms)

150, 160, ..., 500 230 (DR); 250 (VR) (Tolerance ± 5

ms)

Maximum Paced AV Delayag(ms) 30, 40, ..., 400 180(Tolerance±5ms)

Minimum Paced AV Delayag(ms) 30, 40, ..., 400 80 (Tolerance ± 5 ms)

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PROGRAMMABLE OPTIONS A-11

Table A-12. Pacing therapy parameters (Normal, Post-Therapy, and Temporary) (speciﬁed into a 750 Ω

load) (continued)

Parameter Programmable Values Nominal

Maximum Sensed AV Delayag(ms) 30, 40, ..., 400 150(Tolerance±5ms)

Minimum Sensed AV Delayag(ms) 30, 40, ..., 400 65 (Tolerance ± 5 ms)

AV Search +gj Off, On Off

AV Search + Search Intervalgj

(cycles)

32, 64, 128, 256, 512, 1024 32 (Tolerance ± 1 cycle)

AV Search + Search AV Delaygj

(ms)

30,40 ..., 400 300(Tolerance±5ms)

Respiratory Sensorag Off, On On

Rate Hysteresis Hysteresis Offsetg

j( ppm)

-80, -75, ... ,-5, Off Off (Tolerance ± 5 ms)

Rate Hysteresis Search Hysteresisg

j(cycles)

Off, 256, 512, 1024, 2048, 4096 Off (Tolerance ± 1 cycle)

Rate Smoothing (up, down)gj(%) Off, 3, 6, 9, 12, 15, 18, 21, 25 Off (Tolerance 1%)

Noise Responseagl AOO, VOO, DOO, Inhibit Pacing DOO for DDD(R) and DDI(R)

modes; VOO for VDD(R) and VVI(R)

modes; AOO for AAI(R) mode

Maximum Pacing Rateag (ppm) 30, 35, ... ,185 130(Tolerance±5ms)

Post-therapy Pacing Period

(min:sec) (available post-shock

only)

00:15, 00:30, 00:45, 01:00, 01:30,

02:00, 03:00, 04:00, 05:00, 10:00,

15:00, 30:00, 45:00, and 60:00

00:30 (Tolerance ± 1 cardiac cycle)

a. The programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing.

b. Refer to the NASPE/BPEG codes below for an explanation of the programmable values. The identiﬁcation code of the North

American Society of Pacing and Electrophysiology (NASPE) and the British Pacing and Electrophysiology Group (BPEG) is based

on the categories listed in the table.

c. The basic pulse period is equal to the pacing rate and the pulse interval (no hysteresis). Runaway protection circuitry inhibits

bradycardia pacing above 205 ppm. Magnet application does not affect pacing rate (test pulse interval).

d. Separately programmable for ATP/Post-Shock, Temporary Brady, and EP Test.

e. The minimum value of energy delivered at 5 V and 0.5 ms is 20 µJ with 200–500 Ω, and 12 µJ with 1000 Ωresistive load

at 37°C ± 1°C for BOL and Explant.

f. Values are not affected by temperature variation within the range 20°–43°C.

g. This parameter is used globally in Normal Brady pacing and Post-shock Brady pacing. Changing the value for Normal Brady will

change the value for Post-shock Brady.

h. This parameter is automatically set to at least 85 ms for Post-Shock Brady.

i. This parameter is automatically adjusted in Post-Shock Brady to allow appropriate sensing.

j. This parameter is disabled during Temporary Brady.

k. The programmable values for VR devices only include VVI(R), Off; Temporary: VVI, VOO, Off

l. The programmable values for VR devices only includes VOO and Inhibit Pacing and as such the nominal is VOO.

Table A-13. Atrial Tachy Parameters

Parameter Programmable Values Nominal

ATR Mode Switchab Off, On On

ATR Trigger Rateab( bpm) 100, 110, ..., 300 170(Tolerance±5ms)

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A-12 PROGRAMMABLE OPTIONS

Table A-13. Atrial Tachy Parameters (continued)

Parameter Programmable Values Nominal

ATR Durationab(cycles) 0, 8, 16, 32, 64, 128, 256, 512,

1024, 2048

8(Tolerance±1cardiaccycle)

Entry Countab(cycles) 1, 2, ..., 8 8

Exit Countab(cycles) 1, 2, ..., 8 8

ATR Fallback Modeab VDI, DDI, VDIR, DDIR DDI

ATR Fallback Timeab(min:sec) 0, 0:15, 0:30, 0:45, 1:00, 1:15, 1:30,

1:45, 2:00

0:30

ATR/VTR Fallback LRLab( ppm) 30, 35, ..., 185 70 (Tolerance ± 5 ms)

ATR VRRab Off, On On

ATR Maximum Pacing Rateab

( ppm)

30, 35, ..., 185 130

Atrial Flutter Responsebc Off, On Off

Atrial Flutter Response Ratebc

( bpm)

100, 110, ..., 300 170(Tolerance±5ms)

PMT Terminationbc Off, On On

VRRbc Off, On Off

a. The programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing.

b. This parameter is used globally in Normal Brady pacing and Post-shock Brady pacing. Changing the value for Normal Brady will

change the value for Post-shock Brady.

c. This parameter gets disabled during Temporary Brady.

Table A-14. Brady Mode values based on NASPE/BPEG codes

Position I II III IV V

Category Chambers

Paced

Chambers

Sensed

Response

to Sensing

Programmability,

rate modulation

Antitachyarrhythmia

Functions

Letters 0–None 0–None 0–None 0–None 0–None

A–Atrium A–Atrium T–Triggered P–Simple

Programmable

P–Pacing

(Antitachyarrhythmia)

V–Ventricle V–Ventricle I–Inhibited M–Multiprogrammable S–Shock

D–Dual (A&V) D–Dual (A&V) D–Dual (T&I) C–Communicating D–Dual (P&S)

R–Rate Modulation

Mfrs.

Designation

Only

S–Single (A or

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PROGRAMMABLE OPTIONS A-13

Table A-15. Magnet and Beeper functions

Parameter Programmable Values Nominal

Magnet Response Off, Store EGM, Inhibit Therapy Inhibit Therapy

Beep During Capacitor Charge Off, On Off

Beep When Explant is Indicated Off, On On

Table A-16. Sensitivity Adjustment

Parameter Programmable Values Nominal

Atrial Sensitivity AGC 0.15, AGC 0.2, AGC 0.25,

AGC 0.3, AGC 0.4, ..., AGC 1.0,

AGC 1.5

AGC 0.25

Right Ventricular Sensitivity AGC 0.15, AGC 0.2, AGC 0.25,

AGC 0.3, AGC 0.4, ..., AGC 1.0,

AGC 1.5

AGC 0.6

Table A-17. Ventricular Commanded ATP

ParameteraProgrammable Values Nominal

Commanded Ventricular ATP (Type) Burst, Ramp, Scan, Ramp/Scan Burst

Number Of Bursts 1, 2, ..., 30 30

Initial Pulses per Burst (pulses) 1, 2, ..., 30 4

Pulse Increment (pulses) 0, 1, .., 5 0

Maximum Number of Pulses 1, 2, ..., 30 4

Coupling Interval (% or ms) 50, 53, 56, 59; 63, 66, ..., 84; 88, 91,

94, 97% or 120, 130, ..., 750 ms

81%(Tolerance±5ms)

Coupling Interval Decrement (ms) 0, 2, ..., 30 0(Tolerance±5ms)

Burst Cycle Length (BCL) (% or ms) 50, 53, 56, 59; 63, 66, ..., 84; 88, 91,

94, 97% or 120, 130, ..., 750 ms

81%(Tolerance±5ms)

Ramp Decrement (ms) 0, 2, ..., 30 0(Tolerance±5ms)

Scan Decrement (ms) 0, 2, ..., 30 0(Tolerance±5ms)

Minimum Interval (ms) 120, 130, ..., 400 200(Tolerance±5ms)

a. The ventricular Commanded ATP Pulse Width and Amplitude values are the same as programmed for ventricular ATP therapy.

Table A-18. 50 Hz/Manual Burst Pacing

ParameteraProgrammable Values Nominal

Burst Interval (ms) 20, 30, ..., 750 600(Tolerance±5ms)

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A-14 PROGRAMMABLE OPTIONS

Table A-18. 50 Hz/Manual Burst Pacing (continued)

ParameteraProgrammable Values Nominal

Minimum Interval (ms) 20, 30, ...,750 200(Tolerance±5ms)

Decrement (ms) 0, 10, ..., 50 50 (Tolerance ± 5 ms)

a. Applied to the atrium or ventricle depending on the chamber selected.

Table A-19. Ventricular Commanded Shock

Parameter Programmable Values Nominal

Shock (stored energy) (J) 0.1, 0.3, 0.6, 0.9, 1.1, 1.7, 2, 3, 5, 6,

7, 9, 11, 14, 17, 21, 23, 26, 29, 31,

36 (HE), 41 (HE)

41 (Tolerance ± 60% for ≤0.3 J; ±

40% for ≤0.6–3 J; ± 20% for 5–36

J, ± 10% for 41 J)

Coupling Interval (ms) Sync, 50, 60, ..., 500 Sync

Table A-20. VFib (Ventricular Fibrillation) Induction

Parameter Values

VFib High 15V (nonprogrammable) (Tolerance ± 10V)

VFib Low 9V (nonprogrammable) (Tolerance ± 7V)

Table A-21. Shock on T Induction

Parameter Programmable Values Nominal

Shock (stored energy) (J) 0.1, 0.3, 0.6, 0.9, 1.1, 1.7, 2, 3, 5, 6,

7, 9, 11, 14, 17, 21, 23, 26, 29, 31,

36 (HE), 41 (HE)

1.1 J (Tolerance ± 60% for ≤0.3 J;

± 40% for ≤0.6–3 J; ± 20% for 5–36

J, ± 10% for 41 J)

Number of S1 Pulses 1, 2, ..., 30 8

S1 Interval (ms) 120, 130, ..., 750 400

Coupling Interval (ms) Sync, 10, 20, , ..., 500 310

Table A-22. PES (Programmed Electrical Stimulation)

ParameteraProgrammable Values Nominal

Number of S1 Intervals (pulses) 1, 2, ..., 30 8

S2 Decrement 0, 10, ..., 50 0

S1 Interval (ms) 120, 130, ..., 750 600(Tolerance±5ms)

S2 Interval (ms) Off, 120, 130, ..., 750 600 (Tolerance ± 5 ms)

S3 Interval (ms) Off, 120, 130, ..., 750 Off (Tolerance ± 5 ms)

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PROGRAMMABLE OPTIONS A-15

Table A-22. PES (Programmed Electrical Stimulation) (continued)

ParameteraProgrammable Values Nominal

S4 Interval (ms) Off, 120, 130, ..., 750 Off (Tolerance ± 5 ms)

S5 Interval (ms) Off, 120, 130, ..., 750 Off (Tolerance ± 5 ms)

a. Applied to the atrium or right ventricle as commanded by the programmer.

- DRAFT -

A-16 PROGRAMMABLE OPTIONS

- DRAFT -

B-1

PACEMAKER INTERACTION

APPENDIX B

There may be instances where patients may have a separate temporary or

permanent pacemaker. Temporary or permanent pacemakers can interact

with an ICD and can interfere with the identiﬁcation of tachyarrhythmias in

the following ways:

• During a tachyarrhythmia, if the pacemaker does not sense the arrhythmia

and paces, and the pacing pulse detected from the ICD rate-sensing

electrode is large enough, it could cause the ICD to interpret the pacing

as a normal rhythm at the rate of the pacemaker. The ICD would neither

detect the arrhythmia nor deliver therapy.

• The pacemaker could present signals to the ICD resulting from the

following events:

– Inappropriate sensing

– Lead dislodgment

– Failure to capture

This could cause the ICD’s rate measurement to be faster than the patient’s

actual heart rate. As a result, the ICD could deliver inappropriate therapy.

• Conduction delay could cause the ICD to count both pacemaker artifact and

ventricular depolarization. This could result in inappropriate ICD therapy.

For these reasons, the use of a pacemaker that results in pacemaker and ICD

interaction is not recommended. Unipolar pacemakers are contraindicated for

usewithanICD.

Consider the following actions if a separate pacemaker is used:

• Always deactivate a patient’s ICD when:

– Using temporary bipolar or temporary AV sequential pacing

– Reprogramming a separate implanted pacemaker

If cardioversion or deﬁbrillation is needed at such times, use an external

deﬁbrillator.

- DRAFT -

B-2 PACEMAKER INTERACTION

• The ICD rate-sensing electrodes should be as far from the pacing

electrodes as possible.

• After implanting the pacing leads, examine the signals from the ICD

rate-sensing electrodes to ensure that minimal pacemaker artifacts are

present.

• Since it is difﬁcult to predict the relative magnitudes of pacemaker artifacts

and various tachyarrhythmia electrograms that may occur chronically or

during EP testing, it is important to reduce artifacts to a minimum.

• All of the patient’s rhythms should be induced while the ICD is activated

and the separate pacemaker is programmed to an asynchronous mode at

maximum output. This should provide the greatest opportunity for inhibition

of arrhythmia detection due to pacemaker artifacts. Leads may have to be

repositioned to eliminate artifacts.

• To reduce the possibility of pacemaker interaction, consider testing the

separate pacemaker by programming it to the following settings:

– The lowest amplitude allowable for safe capture in the chronic state

– The maximum sensitivity to ensure that pacing is inhibited during VF

– The minimum cardiac rate acceptable for the patient

Also consider using rate-sensing and pacemaker leads with close

intraelectrode spacing (e.g., 11 mm).

• Consider turning off the bradycardia pacing function of the ICD or

programming that function to a rate less than the separate pacemaker rate.

• For pacing control following any shock therapy, consider whether to use the

ICD’s post-therapy bradycardia pacing feature at higher rates and outputs

or the separate pacemaker.

The following test procedure aids in determining the potential for

pacemaker/ICD interaction (Figure B-1 on page B-3).

- DRAFT -

PACEMAKER INTERACTION B-3

Test for inappropriate tachy therapy

due to multiple counting of pacing

artifacts/depolarization.

Observe the electrogram on the

rate-sensing electrodes by reviewing

the rate-sensing recording on the

PRM programming system. Note the

amplitude of the pacing artifact on the

ICD pulse generator rate-sensing

electrogram. If the amplitude of the

pacing artifact is 1/3 or more of the

R-wave amplitude, reposition the

rate-sensing electrodes.

Program pulse generator ventricular

mode on Monitor Only. Enable event

markers.

Program PSA/pacemaker to either a

rate greater than the intrinsic rate or

an asynchronous mode (e.g., DOO,

AOO, VOO).

If multiple counting is noted, reposition

the pacing leads and/or rate-sensing

electrode as appropriate.

If it was necessary to decrease

pacemaker output settings during

testing, to eliminate multiple counting,

record maximum allowable settings

for future reference should the need

for reprogramming occur.

STEP ONE STEP THREE STEP TWO

Test for inappropriate inhibition of

tachy therapy due to detection of

pacing artifacts instead of the

arrhythmia.

Test all tachyarrhythmias.

Enable pulse generator event

markers.

Program PSA/pacemaker to an

asynchronous mode (e.g., DOO,

AOO, VOO) at maximum amplitude

and pulse width.

Verify appropriate nondetection of

pacing artifact.

Induce tachyarrhythmia. Observe

event markers and electrogram

for pacing artifact.

BE PREPARED TO DELIVER A STAT

ICD SHOCK IF THE ARRHYTHMIA

IS NOT SENSED.

If inappropriate therapy inhibition is

noted, reduce pacemaker output

and/or reposition rate-sensing leads.

REPEAT ICD CONVERSION MUST

THEN BE PERFORMED.

If it was necessary to decrease output

settings during testing, to prevent

oversensing of pacing artifact during

the arrhythmia, record maximum

allowable settings for future reference

should the need for reprogramming

occur.

NOTE: The Guidant Model 6860 Magnet also can be used to assess pacemaker interaction if the magnet function is enabled.

Placing the magnet over a device in a ventricular Monitor + Therapy mode should produce tones.

Final device programming.

Following conversion testing,

reinterrogate the pacemaker to ensure

that the mode or other parameters

have not been altered or that the ICD

pulse generator shock did not damage

the pacemaker.

Program pacemaker to desired mode,

rate, amplitudes, and pulse widths.

Record if the programmed pacing

output is sufficient to ensure capture

post-shock; if not, consider

programming the ICD pulse generator

post-shock pacing at high outputs and

at a rate greater than the pacemaker

rate.

Figure B-1. Test procedure for pacemaker-ICD interaction

- DRAFT -

B-4 PACEMAKER INTERACTION

- DRAFT -

C-1

CLINICAL STUDY - MADIT II

APPENDIX C

SUMMARY

Guidant Cardiac Rhythm Management has received FDA approval for the

following expanded indications for patients identiﬁed by the Multicenter

Automatic Deﬁbrillator Implantation Trial II (MADIT II) to be at high risk for

sudden cardiac death.

The Multicenter Automatic Deﬁbrillator Implantation Trial II (MADIT II) was

designed to determine if implantation of an ICD in high-risk cardiac patients

with advanced left ventricular dysfunction could improve overall survival. The

previous MADIT I trial demonstrated improved overall survival with an ICD

in high-risk patients with coronary heart disease, left ventricular dysfunction,

asymptomatic nonsustained ventricular tachyarrhythmias and an inducible

nonsuppressible ventricular tachycardia at EP study.

INDICATIONS FOR USE

Guidant implantable cardioverter deﬁbrillators (ICDs) are indicated in patients

who have had spontaneous and/or inducible life-threatening ventricular

arrhythmias and those who are at high risk for developing such arrhythmias. In

addition, this device is indicated for prophylactic treatment of patients with a

prior myocardial infarction and an ejection fraction (EF) ≤30%.

OBSERVED ADVERSE EVENTS

The Multicenter Automatic Deﬁbrillator Implantation Trial II (MADIT II) was a

prospective, randomized, controlled, multicenter, unblinded study conducted at

76 sites (71 in the United States and 5 in Europe) and enrolled a total of 1,232

patients. Patients were randomly assigned in a 3:2 ratio to receive an ICD (742

patients) or conventional medical therapy (490 patients). There were a total of

22 conventional therapy patients that were crossed over to the ICD group and a

total of 32 patients randomized to the ICD arm that were considered crossovers.

Of these 32 crossovers, 11 were due to subsequent device explants.

There were no unanticipated adverse events reported in the MADIT II study

as of December 7, 2001. There were no patient deaths that occurred during

implantation. Table C-1 on page C-2 provides information on all adverse events

reported from implant through the randomization period in patients attempted or

implanted with the MADIT II criteria. The table includes a total of 3,161 events

- DRAFT -

C-2 CLINICAL STUDY - MADIT II

reported for a total of 1,206 patients as of the data cutoff date of January 16,

2002. The number of patients is less than the total enrolled 1,232 patients

because not all patients had reached the point of the one-month follow-up. The

observed adverse events do not reﬂect an intention-to-treat analysis.

Table C-1. Adverse events through the randomization period

Adverse Event # Of Events

(# of pts)a

Complications

(Patients)

Complications

per 100

Device Months

(Events)

Observations

(Patients)

Observations per

100 Device Months

(Events)

Total of All Adverse

Events (AE)

3161 (813a) 49.7 (599) 7.9 (1761) 46.9 (566) 6.3 (1400)

ICD Therapy (Total

AEs–treatment

group)

2105 (503) 51.5 (376) 8.4 (1172) 49.9 (364) 6.7 (933)

Conventional

Therapy (Total

AEs–control

group)

1056 (310) 46.8 (223) 7.0 (589) 42.4 (202) 5.5 (476)

TOTAL CARDIOVASCULAR RELATED ADVERSE EVENTS

Device-Related Eventsb

Prophylactic

replacement

7 (7) 0.6 (7) 0.0 (7) 0.0 (0) 0.0 (0)

Lead related

problem

14 (13) 0.8 (10) 0.0 (10) 0.3 (3) 0.0 (4)

Battery depletion –

normal (at EOL)

2 (2) 0.2 (2) 0.0 (2) 0.0 (0) 0.0 (0)

Electromagnetic

interference (EMI)

2 (2) 0.0 (0) 0.0 (0) 0.2 (2) 0.0 (2)

Nonconversion of

arrhythmia

3 (3) 0.2 (3) 0.0 (3) 0.0 (0) 0.0 (0)

Sense time

prolonged /

inappropriate

5 (5) 0.2 (3) 0.0 (3) 0.2 (2) 0.0 (2)

Generator

manufacturing

problem

2 (2) 0.2 (2) 0.0 (2) 0.0 (0) 0.0 (0)

Pacemaker

mediated

tachycardia

79 (47) 0.0 (0) 0.0 (0) 3.9 (47) 0.4 (79)

Individual events

that occurred one

time

18 (18) 1.0 (10) 0.0 (10) 0.8 (8) 0.0 (8)

- DRAFT -

CLINICAL STUDY - MADIT II C-3

Table C-1. Adverse events through the randomization period (continued)

Adverse Event # Of Events

(# of pts)a

Complications

(Patients)

Complications

per 100

Device Months

(Events)

Observations

(Patients)

Observations per

100 Device Months

(Events)

Subtotal Device

Related Events

132 (91a) 2.9 (35) 0.2 (37) 4.9 (59) 0.4 (95)

Procedure Related Eventsb

Infection 13 (13) 0.8 (9) 0.0 (9) 0.3 (4) 0.0 (4)

Lead problem 2 (2) 0.1 (1) 0.0 (1) 0.1 (1) 0.0 (1)

Patient bleeding 2 (2) 0.1 (1) 0.0 (1) 0.1 (1) 0.0 (1)

Pulse generator

ﬂipped (Twiddler)

2 (2) 0.0 (0) 0.0 (0) 0.2 (2) 0.0 (2)

Pocket

inﬂammation/hematoma

15 (15) 0.9 (11) 0.0 (11) 0.3 (4) 0.0 (4)

Pain 10 (10) 0.1 (1) 0.0 (1) 0.7 (9) 0.0 (9)

Fibrillation, atrial 2 (2) 0.0 (0) 0.0 (0) 0.2 (2) 0.0 (2)

Deep Vein

Thrombosis

3 (3) 0.1 (1) 0.0 (1) 0.2 (2) 0.0 (2)

Anxiety 2 (2) 0.0 (0) 0.0 (0) 0.2 (2) 0.0 (2)

Individual events

that occurred one

time

17 (17) 0.8 (8) 0.0 (8) 0.9 (9) 0.0 (9)

Subtotal

Procedure Related

Events

68 (59a) 2.2 (26) 0.1 (32) 3.0 (36) 0.2 (36)

Cardiovascular Related Events (n=730 pts): ICD Therapy (treatment group)

Arrhythmia, atrial 78 (66) 4.2 (31) 0.2 (34) 5.3 (39) 5.3 (39)

Arrhythmia,

ventricular

64 (49) 5.3 (39) 0.4 (53) 1.4 (10) 0.1 (11)

Mitral valve

regurgitation

1 (1) 0.1 (1) 0.0 (1) 0.0 (0) 0.0 (0)

Congestive heart

failure

444 (227) 22.9 (167) 2.2 (304) 14.1 (103) 1.0 (140)

Palpitation,

pounding heart

21 (18) 1.0 (7) 0.1 (7) 1.5 (11) 0.1 (14)

Syncope 62 (50) 4.7 (34) 0.3 (40) 2.5 (18) 0.2 (22)

Infarction,

myocardial

34 (28) 3.8 (28) 0.2 (34) 0.0 (0) 0.0 (0)

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C-4 CLINICAL STUDY - MADIT II

Table C-1. Adverse events through the randomization period (continued)

Adverse Event # Of Events

(# of pts)a

Complications

(Patients)

Complications

per 100

Device Months

(Events)

Observations

(Patients)

Observations per

100 Device Months

(Events)

Angina pectoris 166 (110) 10.0 (73) 0.8 (112) 6.0 (44) 0.4 (54)

Bradycardia, sinus 8 (8) 1.0 (7) 0.1 (7) 0.1 (1) 0.0 (1)

Tachycardia 7 (7) 0.3 (2) 0.0 (2) 0.7 (5) 0.0 (5)

AV Block,

Complete

1 (1) 0.1 (1) 0.1 (1) 0.0 (0) 0.0 (0)

Cardiac allograft

rejection

2 (2) 0.3 (2) 0.0 (2) 0.0 (0) 0.0 (0)

Hypotension 28 (26) 1.4 (10) 0.1 (10) 2.2 (16) 0.1 (18)

Hypertension 6 (6) 0.1 (1) 0.0 (1) 0.7 (5) 0.0 (5)

Claudication 10 (7) 0.8 (6) 0.1 (9) 0.1 (1) 0.0 (1)

Carotid stenosis 5 (5) 0.5 (4) 0.0 (4) 0.1 (1) 0.0 (1)

Aneurysm 1 (1) 0.1 (1) 0.0 (1) 0.0 (0) 0.0 (0)

Deep vein

thrombosis

9 (9) 1.0 (7) 0.1 (7) 0.3 (2) 0.0 (2)

Pulmonary

Embolus

4 (4) 0.5 (4) 0.0 (4) 0.0 (0) 0.0 (0)

Individual events

that occurred one

time

5 (5) 0.5 (4) 0.0 (4) 0.1 (1) 0.0 (1)

Subtotal

Cardiovascular

Related Events:

ICD Therapy

(treatment group)

956 (354) 36.8 (269) 4.6 (637) 26.8 (196) 2.3 (319)

Cardiovascular Related Events (n=476 pts): Conventional Therapy (control group)

Arrhythmia, atrial 31 (29) 3.2 (15) 0.2 (16) 3.2 (15) 0.2 (15)

Arrhythmia,

ventricular

33 (26) 4.6 (22) 0.3 (27) 1.1 (5) 0.1 (6)

Arrhythmia,

general report

3 (3) 0.4 (2) 0.0 (2) 0.2 (1) 0.0 (1)

Mitral valve

regurgitation

1 (1) 0.2 (1) 0.0 (1) 0.0 (0) 0.0 (0)

Congestive heart

failure

212 (128) 16.6 (79) 1.5 (126) 14.3 (68) 1.0 (86)

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CLINICAL STUDY - MADIT II C-5

Table C-1. Adverse events through the randomization period (continued)

Adverse Event # Of Events

(# of pts)a

Complications

(Patients)

Complications

per 100

Device Months

(Events)

Observations

(Patients)

Observations per

100 Device Months

(Events)

Palpitation,

pounding heart

6 (5) 0.4 (2) 0.0 (3) 0.6 (3) 0.0 (3)

Syncope 35 (31) 4.8 (23) 0.3 (24) 2.1 (10) 0.1 (11)

Infarction,

myocardial

19 (17) 3.6 (17) 0.2 (19) 0.0 (0) 0.0 (0)

Angina pectoris 93 (71) 10.7 (51) 0.8 (64) 5.5 (26) 0.3 (29)

Bradycardia, sinus 8 (8) 1.7 (8) 0.1 (8) 0.0 (0) 0.0 (0)

AV Block,

Complete

4 (2) 0.4 (2) 0.0 (3) 0.2 (1) 0.0 (1)

Bundle branch

block

4 (4) 0.4 (2) 0.0 (2) 0.4 (2) 0.0 (2)

Hypotension 17 (13) 1.9 (9) 0.1 (12) 1.1 (5) 0.1 (5)

Hypertension 2 (2) 0.0 (0) 0.0 (0) 0.4 (2) 0.0 (2)

Claudication 6 (4) 0.6 (3) 0.1 (5) 0.2 (1) 0.0 (1)

Carotid stenosis 5 (5) 1.1 (5) 0.1 (5) 0.0 (0) 0.0 (0)

Aneurysm 3 (3) 0.6 (3) 0.0 (3) 0.0 (0) 0.0 (0)

Deep vein

thrombosis

3 (3) 0.6 (3) 0.0 (3) 0.0 (0) 0.0 (0)

Pulmonary

Embolus

2 (2) 0.4 (2) 0.0 (2) 0.0 (0) 0.0 (0)

Tachycardia 2 (2) 0.2 (1) 0.0 (1) 0.2 (1) 0.0 (1)

Individual events

that occurred one

time

7 (7) 1.1 (5) 0.1 (5) 0.4 (2) 0.0 (2)

Subtotal

Cardiovascular

Related Events:

Conventional

Therapy (control

group)

496 (222) 34.7 (165) 3.9 (329) 25.0 (119) 2.0 (165)

Subtotal

Cardiovascular

Related Events:

Both groups

1452 (576a) 36.0 (434) 4.3 (968) 26.1 (315) 2.2 (484)

a. Identiﬁes number of unique patients. Patients may have one or more adverse events.

b. Events include only patients in the ICD treatment group.

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C-6 CLINICAL STUDY - MADIT II

MORTALITY

There were a total of 202 deaths that occurred during the trial and recorded as

of the stop date, November 20, 2001. These deaths occurred during the study

periods as shown in Table C-2 on page C-6 along with the cause of death as

adjudicated by an independent events committee.

Table C-2. Cause of death during the treatment period

Cause of Death

(as a percent of total pts)

ICD Therapy

(N=742) Patients (%)

Conventional Therapy

(N=490) Patients (%)

Total

(N=202)

Noncardiac 25 (3.4%) 21 (4.3%) 46 (3.7%)

Cardiac: Arrhythmic 28 (3.8%) 48 (9.8%) 76 (6.2%)

Cardiac: Nonarrhythmic 45 (6.1%) 22 (4.5%) 67 (5.4%)

Cardiac: Undetermined cause 1 (0.1%) 2 (0.4%) 3 (0.2%)

Unknown 6 (0.8%) 4 (0.8%) 10 (0.8%)

Total Deaths 105 (14.2%) 97 (19.8%) 202 (16.3%)

SUMMARY OF CLINICAL STUDY

Guidant supported the MADIT II Clinical Study as conducted by the University

of Rochester to evaluate the potential survival beneﬁt of a prophylactically

implanted ICD in patients with a prior myocardial infarction and a left ventricular

ejection of ≤30 percent. Unlike MADIT I1, patients enrolled in MADIT II were

not required to undergo electrophysiologic testing to induce arrhythmias prior to

implant. Patients were randomized to either ICD or conventional therapy. All

cause mortality was the primary endpoint of the study.

The MADIT II trial was monitored using a sequential design and on November

20, 2001, after review of the data by the Data and Safety Monitoring Board, the

study was stopped. Results of the trial data indicated a 31percent decrease in

the mortality rate in patients implanted with an ICD device compared to patients

randomized to the conventional therapy group, thus meeting its effectiveness

endpoint.

The trial began July 11, 1997 and was conducted over a period of four years at

76 investigational centers both within and outside the United States.

1. Moss AJ, Hall WJ, Cannom DS, et al. Improved survival with an implanted deﬁbrillator in

patients with coronary disease at high risk for ventricular arrhythmia. NEJM 1996;335:1993-40

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CLINICAL STUDY - MADIT II C-7

STUDY DESIGN

MADIT II was a prospective, randomized (3:2 ICD to conventional non-ICD

therapy), controlled, unblinded, multicenter trial. Randomization to the ICD

group consisted of implantation of a legally marketed Guidant ICD device.

Randomization to the conventional therapy group consisted of beta-adrenergic

blocking drugs and angiotensin-converting enzyme (ACE) inhibitors when

indicated.

Patients provided written informed consent and received a baseline reference

examination that included prior clinical history, physical examination and a

12-lead ECG. Following completion of the baseline evaluation, patients were

randomized by the Coordination and Data Center (CDC) in a 3:2 fashion to

receive either an ICD or conventional medical therapy; randomization was

done separately for each center, with blocking, to assure proper balance

between the two treatment groups within each center. Each randomized patient

remained counted as a member of the original randomization assignment

(intention-to-treat) regardless of subsequent crossover or protocol adherence.

Patients randomized to the ICD arm were implanted with Guidant transvenous

deﬁbrillator devices by MADIT II investigators. All Guidant ICD systems used

during the trial were legally approved devices and the use of investigational

devices was strictly prohibited. Following randomization, patients were seen

at a 1-month follow-up visit in the clinic and at 3-month intervals thereafter

until termination of the study.

Primary Endpoint

The primary endpoint for MADIT II was all cause mortality.

Primary Objective

The primary objective of the trial was to determine if implantation of ICDs in

moderately high-risk coronary patients would result in signiﬁcant reduction in

death when compared to patients treated without an ICD.

Secondary Objectives

The secondary objectives of the trial were as follows:

• Determine if (electrophysiology study) EPS inducibility at ICD implantation

in the ICD group was associated with a higher appropriate ICD discharge

rate during follow-up than noninducibility.

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C-8 CLINICAL STUDY - MADIT II

• Determine if Holter-recorded noninvasive electrocardiologic parameters

(SAECG, heart rate variability, temporal dispersion of refractoriness,

T-wave alternans, and T-wave lability) can identify patients with an

increased mortality rate in the non-ICD group.

• Evaluate the cost-effectiveness of ICDs in saving lives.

• Determine if ICD therapy is associated with an improved quality of life.

The results of these secondary objectives are pending and were not included

as part of the approval for this expanded indication.

INCLUSION/EXCLUSION CRITERIA

Study inclusion criteria were as follows:

• Patients must have an ejection fraction ≤0.30 obtained ≤3monthspriorto

enrollment by angiographic, radionuclide, or echocardiographic methods.

This ejection fraction must be obtained at least 30 days following the most

recent myocardial infarction, coronary artery bypass graft surgery, or

coronary revascularization procedure.

• Patients must have had at least one or more documented Q-wave or other

enzyme positive infarctions. If enzyme information is not available, then

there must be clear evidence of an infarct identiﬁed as a Q-wave on an

ECG, ﬁxed defect (scar) on a thallium scan, or infarcted area on a coronary

angiogram or echocardiography.

• Patients must be men or women greater than 21 years of age (no upper

cut-off).

Studyexclusioncriteriawereasfollows:

• Previous cardiac arrest or syncopal ventricular tachycardia unassociated

with an acute myocardial infarction (existing ICD indication)

• Patients meeting MADIT I criteria with EF ≤0.35, nonsustained VT, and

inducible-nonsuppressible VT at electrophysiologic study (existing ICD

indication)

• Cardiogenic shock, symptomatic hypotension while in a stable baseline

rhythm

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CLINICAL STUDY - MADIT II C-9

• NYHA functional Class IV

• Current use of antiarrhythmic agents except when indicated for atrial

arrhythmias

• Coronary artery bypass graft surgery or PTCA within the past 3 months

• Enzyme-positive myocardial infarction ≤30 days prior to enrollment

• Patients with angiographic evidence of coronary disease who are

candidates for coronary revascularization and are likely to undergo

coronary artery bypass graft surgery or PTCA in the foreseeable future

• Patients with irreversible brain damage from preexisting cerebral disease

• Women of childbearing potential not using medically prescribed

contraceptive measures

• Presence of any disease, other than the patient’s cardiac disease,

associated with a reduced likelihood of survival for the duration of the trial,

e.g., cancer, uremia (BUN ≥70 mg% and/or creatinine ≥30 mg%)

• Patients participating in other clinical heart disease trials

• Patients unwilling or unable to cooperate with the study due to dementia,

psychological, or other related reasons

• Patients who were unable to participate due to one or more logistical

considerations

• Patient’s primary care physician refuses to allow patient to participate

• Patients who are on the heart transplant list. If the patient is pending

evaluation for the heart transplant list, the patient cannot be enrolled in

MADIT II until it is deﬁnitively determined that the patient will NOT be

placed on the transplant list

• ICD cannot be implanted due to anatomical abnormality or other medical

problem

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C-10 CLINICAL STUDY - MADIT II

PATIENT STATUS

There were a total of 1,232 patients with a prior myocardial infarction and a

left ventricular ejection fraction of ≤0.30 enrolled in the MADIT II trial. A total

of 742 patients were randomized to receive an ICD and 490 patients were

randomized to conventional therapy. Figure C-1 on page C-10 provides an

overview of the patient enrollment.

Patients Enrolled

n = 1232*

ICD

(device)

n = 742

Dead

n = 105

Alive

n = 625

Dead

n = 97

Alive

n = 381

Conventional Therapy

(Control)

n = 490

Unknown

n = 12

Unknown

n = 12

* Includes crossovers

(32 in Device arm, 22

in Control arm)

Figure C-1. Patient enrollment cascade primary endpoint

PRIMARY ENDPOINT

The primary endpoint for MADIT II was death from any cause. Analysis was

performed according to the intention-to-treat principle. The trial was designed

to have 95 percent power to detect a 38 percent reduction in the two-year

mortality rate among the patients in the ICD group, given a postulated two-year

mortality rate of 19 percent among patients assigned to conventional therapy,

with a two-sided signiﬁcance level of 5 percent. For proportional-hazards

modeling, power was maintained for a true hazard ratio of 0.63, after allowance

for crossovers. A triangular sequential design was used, which was modiﬁed

for two-sided alternatives. The data was corrected to account for any lag in

obtaining data accrued (during weekly monitoring), but not reported before

the termination of the trial with preset boundaries to permit termination of the

trial if the ICD therapy was found to be superior to, inferior to, or equal to

conventional medical therapy.

Secondary analyses were performed with use of the Cox proportional hazards

regression model. Survival curves were determined according to the Kaplan

and Meier method, with comparisons of cumulative mortality based on

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CLINICAL STUDY - MADIT II C-11

logarithmic transformation. The p-values were termed nominal when they were

not adjusted for sequential monitoring. All p-values were two-tailed.

At the recommendation of the Data and Safety Monitoring Board (DSMB),

the trial was stopped on November 20, 2001, when it was revealed that the

difference in mortality between the two groups had reached the prespeciﬁed

efﬁcacy boundary (p=0.027) (Figure C-2 on page C-11).

0 20 40 60 80

-10

Log-Rank

Statistic

Variance

Vlow = 11.72

Lower Boundary: -11.77 + 0.3819*V

x = 77.8

Upper Boundary: 11.77 + 0.1273*V

Nov. 13, 2001

Dec. 7, 2001

Figure C-2. Sequential monitoring in the triangular design

FOLLOW-UP SCHEDULE

Following randomization, patients were seen at a 1-month follow-up visit in the

clinic and at 3-month intervals thereafter until termination of the study. During

each clinic visit, an appropriate clinical evaluation was completed. Patients with

an ICD device underwent device testing according to an agreed-upon protocol

at the investigational center. Patients were followed from between 6 days and

53 months averaging 20 months.

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C-12 CLINICAL STUDY - MADIT II

STUDY RESULTS

Study Duration

Study duration, measured in months, is displayed in Table C-3 on page C-12.

The mean duration was similar between the ICD group and the conventional

therapy group. As expected, the ICD group accumulated >15,000 months

of follow-up.

Table C-3. Study duration in months

Therapy No. Mean ±SD Minimum Maximum Cumulative

ICD Therapy 742 20.5 12.9 0.2 51.7 15,190

Conventional Therapy 490 19.6 12.6 0.2 52.3 9,624

Demographic Data

Table C-4 on page C-12 provides a summary of the general characteristics of

the enrolled MADIT II patient population. Characteristics were balanced across

therapy groups and no statistical differences were found during data analysis

as indicated by the p-values in the table.

Table C-4. Patient population characteristics

Characteristic ICD Patients

(n=742)

Conventional

Therapy Patients

(n=490)

p-value

Age at Enrollment

> 65 years (patients, %) 397 (53.5%) 262 (53.5%)

Mean ± Standard Deviation (years) 64.4 ± 10.4 64.6 ± 10.3

0.99

Gender (patients, %)

Male 623 (83.9%) 417 (85.1%) 0.59

LVEF (%)

Mean ± Standard Deviation 23.1 ± 5.4 23.2 ± 5.6 0.93

LVEFa

≤25% (patients, %) 502 (76.7%) 330 (67.3%) 0.91

New York Heart Association Classiﬁcation 3 months before enrollment (patients, %)

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CLINICAL STUDY - MADIT II C-13

Table C-4. Patient population characteristics (continued)

Characteristic ICD Patients

(n=742)

Conventional

Therapy Patients

(n=490)

p-value

No CHF 179 (24.1%) 129 (26.3%)

Class I 75 (10.1%) 58 (11.8%)

Class II 258 (34.8%) 162 (33.1%)

Class III 187 (25.2%) 111 (22.7%)

Class IV 33 (4.5%) 20 (4.1%)

Unknown 10 (1.4%) 10 (2.0%)

0.64

Canadian Heart Association Classiﬁcation

Class I 126 (16.9%) 81 (16.5%)

Class II, III, IV 168 (23.1%) 120 (24.4%)

Angina Decubitus 35 (4.7%) 15 (3.1%)

No Angina Pectoris 402 (54.1%) 268 (54.7%)

Unknown 11 (1.4%) 6 (1.2%)

0.62

Other

Ventricular arrhythmias requiring treatment (patients,

74 (10.0%) 64 (13.1%) 0.24

Atrial Arrhythmias requiring treatment (patients, %) 201 (27.1%) 120 (24.4%) 0.56

History of Hypertension (patients, %) 411 (55.3%) 277 (56.5%) 0.71

Blood Urea Nitrogen (patients, %) > 25 mg % 213 (28.7%) 153 (31.2%) 0.52

Diabetes Mellitus (patients, %) 246 (33.2%) 184 (37.6%) 0.45

Non-CABG Revascularization Procedures (patients, %) 331 (44.6%) 205 (41.8%) 0.56

CABG Surgery (patients, %) 428 (57.7%) 274 (55.9%) 0.53

Permanent Pacemaker (patients, %) 62 (8.4%) 30 (6.1%) 0.22

EP Study prior to enrollment (262 patients) n=150 (20.2%) n=112 (22.8%) 0.27

Inducible 8(5.3%) 2(1.8%) 0.25

a. Two patients enrolled with EF > 30%.

Medications

Table C-5 on page C-14 provides a summary of the medication utilization for the

patients enrolled. The two treatment groups were balanced and appropriately

treated with standard cardiac therapy. There were no differences in ACE

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C-14 CLINICAL STUDY - MADIT II

inhibitors, beta blockers, or digitalis therapy between the ICD therapy group

and the conventional therapy patients.

Table C-5. Patient population medication therapy

Medication ICD Patients

(n = 742)

Conventional Therapy

Patients

(n = 490)

p-value

ACE inhibitor use (patients, %)

Baseline/Enrollment 574 (77.4%) 377 (76.9%) 0.47

Last Follow-up 533 (71.8%) 363 (74.1%) 0.31

Amiodarone use (patients, %)

Baseline/Enrollment 49 (6.6%) 36 (7.3%) 0.41

Last Follow-up 94 (12.7) 51 (10.4%) 0.23

Antiarrhythmic use (patients, %)

Baseline/Enrollment 18 (2.4%) 15 (3.1%) 0.37

Last Follow-up 21 (2.8%) 12 (2.4%) 0.43

Aspirin use (patients, %)

Baseline/Enrollment 503 (67.8%) 344 (70.2%) 0.30

Last Follow-up 477 (64.3%) 332 (67.8%) 0.20

Beta blocker use (patients, %)

Baseline/Enrollment 469 (63.2%) 295 (60.2%) 0.28

Last Follow-up 529 (71.3%) 351 (71.6%) 0.46

Digitalis use (patients, %)

Baseline/Enrollment 441 (59.4%) 277 (56.5%) 0.29

Last Follow-up 451 (60.8%) 290 (59.2%) 0.41

Diuretics use (patients, %)

Baseline/Enrollment 541 (72.9%) 379 (77.3%) 0.09

Last Follow-up 562 (75.7%) 396 (80.8%) 0.04

Lipid Lowering use (patients, %)

Baseline/Enrollment 492 (66.3%) 315 (64.3%) 0.37

Last Follow-up 556 (74.9%) 339 (69.2%) 0.04

Sotalol use (patients, %)

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CLINICAL STUDY - MADIT II C-15

Table C-5. Patient population medication therapy (continued)

Medication ICD Patients

(n = 742)

Conventional Therapy

Patients

(n = 490)

p-value

Baseline/Enrollment 7 (0.9%) 3 (0.6%) 0.38

Last Follow-up 18 (2.4%) 4 (0.8%) 0.05

All Cause Mortality

The Kaplan Meier mortality curves depicting mortality for the two groups

are shown in Figure C-3 on page C-15. Although the conventional and ICD

survival curves remain close during the ﬁrst nine months, they progressively

separate thereafter. Table C-6 on page C-15 presents information derived from

these curves, with the conclusion that 3-year cumulative all-cause mortality is

estimated to be reduced by 29 percent in those with an ICD.

01234

0.0

0.2

0.4

0.6

0.8

1.0

Probability of All Cause Mortality

Years

ICD Group

Conventional Group

742

490

503

329

274

170

110

Number of patients

ICD:

Conventional:

Figure C-3. Kaplan-Meier Mortality Curve: Conventional vs. ICD groups

Table C-6. Cumulative mortality and percentage reduction

Year Conventional

Arm

ICD Arm Difference Reduction CIa%p-valueb

1 Year 9.9 8.8 1.1 11% -29, 39 0.53

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C-16 CLINICAL STUDY - MADIT II

Table C-6. Cumulative mortality and percentage reduction (continued)

Year Conventional

Arm

ICD Arm Difference Reduction CIa%p-valueb

2 Years 21.5 15.5 6.0 28% 5, 46 0.02

3 Years 30.4 21.6 8.8 29% 6, 46 0.02

a. Indicates Conﬁdence Interval for the percentage reduction in cumulative mortality. The cumulative mortality (and associated

standard errors) is taken from the Kaplan-Meier analyses; percentage reduction analyses are based on a log transform method.

b. For null hypothesis that the percentage (%) reduction is zero.

The pre-speciﬁed primary analysis of the trial was based on computation of a

hazard ratio, based on an assumption that the two survival curves satisfy a

proportional hazards condition (one is a power —the ‘hazard ratio’— of the

other), and recognizing the sequential stopping rule of the trial. The hazard

ratio is interpreted as the ratio of instantaneous risks of dying, at each point in

time, in the two treatment groups. The hazard ratio for the ICD group relative to

the conventional therapy group was found to be 0.69, indicating a 31percent

reduction in instantaneous risk (95 percent conﬁdence interval, 0.51 to 0.93;

p=0.016, reduced from p=0.027 when reaching the stopping boundary, by

incorporation of lagged data). The Cox regression analyses used for this

purpose were stratiﬁed by enrollment centers, thus allowing for somewhat

different patient pools at differing locations.

The proportional hazards assumption was evaluated by several standard

statistical methods, all providing support. One method is derived from

ﬁnding parallelism in so-called log (-log) plots of the cumulative hazards.

Another is from ﬁtting models that allow for differing hazard ratios in differing

intervals of time, and demonstrating that any apparent differences among the

period-speciﬁc hazard ratios can be attributed to chance. One such analysis is

summarizedinTableC-7onpageC-16.

Table C-7. Year-speciﬁc hazard ratio (HR)

Year Estimate CI

1 Year 0.87 0.59, 1.29

2 Years 0.56 0.29, 1.07

3+ Years 0.61 0.28, 1.34

Overall 0.69 0.51, 0.93

The p-value = 0.16 for differences among the 3 HRs, and the p-value = 0.016

for the overall HR. The exponential mortality curves ﬁt the data very well,

with risks of mortality of 0.0100 each month for patients in the conventional

- DRAFT -

CLINICAL STUDY - MADIT II C-17

therapy group and 0.0069 each month in the ICD group, with the ratio, 0.69, in

agreement with that reported above.

Veriﬁcation of ICD Shock Therapy Treatment

Of the 710 patients that were implanted with an ICD, 134 received appropriate

therapy for ventricular tachycardia/ventricular ﬁbrillation (VT/VF) and the

probability of therapy increased over time. There was a 34 percent cumulative

probability that ICD patients received therapy from the device for VT/VF within

three years (Figure C-4 on page C-17). The probability of ﬁrst appropriate

shock for VF only at one year was 4 percent and increased to 10 percent after

four years. These percentages are closely related to the survival probability

differences observed between the ICD and conventional therapy groups (1

percent and 11 percent, respectively) as shown in Figure C-3 on page C-15.

01234

0.0

0.2

0.4

0.6

0.8

1.0

Cumulative Probability of 1st Therapy

Years

Shock for VF

ATP/Shock for VT/VF

Probability of 1st Therapy Due to VT/VF

Figure C-4. Probability of ﬁrst therapy due to VT/VF

The probability of appropriate ICD shocks for ventricular ﬁbrillation (Figure C-4

on page C-17) correlates closely to the difference in the cumulative number of

deaths between the ICD and conventional groups (Figure C-3 on page C-15).

Hospitalization Results

The rate of occurrence of patients requiring hospitalization due to adverse

events was 0.29 per year of observation in both the conventional therapy

patients and in the ICD patients. Table C-8 on page C-18 provides the

summary of all hospitalizations that occurred as a result of adverse events.

Adverse events that resulted in hospitalizations do not differ signiﬁcantly

between groups.

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C-18 CLINICAL STUDY - MADIT II

Table C-8. Adverse events requiring hospitalizations (Rate/Year)

Treatment Group Cumulative Years

of Observation

Total Number of

Individuals with

Adverse Events

Rate per Year of

Individuals with

Adverse Events

p-value

Conventional (n=490) 703.6 201 (41%) 0.29 0.85

ICD Therapy Group

(n=742)

1155.97 337 (45%) 0.29

Table C-9 on page C-18 provides a summary of hospitalizations that were

required as a result of congestive heart failure (CHF) related adverse events.

There were 78 of the 490 patients in the conventional group and 161 of the

742 ICD patients who had one or more hospitalizations that did not result in

death. The annual rate of hospitalization for CHF for each treatment group was

calculated by dividing the number of patients with one or more hospitalizations

for new or worsening CHF by the cumulative years of observation. The rate

of hospitalization for CHF per year was somewhat higher in the ICD group

(161/115.97 = 0.14) compared to the conventional therapy group (78/703.6 =

0.11); however, this difference in the rate of hospitalization for CHF was not

statistically signiﬁcant (p=0.11).

Table C-9. Heart failure adverse events requiring hospitalization (Rate/Year)

Treatment Group Cumulative Years

of Observation

Total Number of

Individuals with

Adverse Events

Rate per Year of

Individuals with

Adverse Events

p-value

Conventional (n=490) 703.6 78 (16%) 0.11 0.11

ICD Therapy Group (n=742) 1155.97 161 (22%) 0.14

Reasons for Crossover

The MADIT II study was an intention-to-treat analysis, therefore, any patient

receiving therapy outside of their randomized therapy group was counted as a

crossover. Table C-10 on page C-18 details crossovers by treatment group.

Table C-10. Reasons for crossovers by treatment group

Description ICD Therapy

(n=742)

Conventional Therapy

(n=490)

Refusal of therapy 21 0

Met ICD implant criteria N/A 21

Heart transplant 9 0

Sepsis related to CABG surgery 10

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CLINICAL STUDY - MADIT II C-19

Table C-10. Reasons for crossovers by treatment group (continued)

Description ICD Therapy

(n=742)

Conventional Therapy

(n=490)

Nonconversion of arrhythmia 10

Physician Discretion 0 1

Total Crossovers (54) 32 22

A crossover patient was deﬁned as a patient who, at the time of a speciﬁed

data cutoff date, was receiving treatment that was different than their originally

randomized assignment. Crossovers from the conventional therapy group to

the ICD group were strongly discouraged unless a patient was determined to

have a strong clinical justiﬁcation such as positive inducibility during EP testing

or spontaneous ventricular arrhythmia event(s) requiring hospitalization that

wouldbeanapprovedindicationforreceivinganICD.

Follow-up Compliance

The compliance rate is calculated by dividing the number of successful

visits by the sum of the visits expected for the designated month sequence.

Table C-11 on page C-19 details reported visit compliance in six-month

intervals. Compliance to follow-up was ≥88 percent at the majority of required

visits. There was no difference in the follow-up rates between the two groups.

Table C-11. Follow-up compliance

Follow-up Sequence Month % Compliant

ICD Group

% Compliant

Conventional Therapy Group

1–6 months 98 96

7–12 months 97 95

13–18 months 96 93

19–24 months 95 93

25–30 months 93 89

31–36 months 97 90

37–42 months 95 85

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C-20 CLINICAL STUDY - MADIT II

Table C-11. Follow-up compliance (continued)

Follow-up Sequence Month % Compliant

ICD Group

% Compliant

Conventional Therapy Group

43–51 months 96 100

Total Average 96 94

Subgroup Analysis of MADIT II Patient Population

Figure C-5 on page C-20 provides the hazard ratios and 95 percent conﬁdence

intervals for death from any cause in the ICD group as compared to the

conventional therapy group according to selected clinical characteristics.

The hazard ratios in the various subgroups were similar, with no statistically

signiﬁcant interactions. The dotted vertical line represents the results for the

entire study (nominal hazard ratio, 0.66, without adjustment for the stopping

rule). The horizontal lines indicate nominal 95 percent conﬁdence intervals.

0.4 0.6 0.8 1.0 1.41.2

ICD Better Conventional Better

Hazard Ratio

ll patients 1232

Age

< 65 yr 573

≥ 65 yr 659

Sex

Male 1040

Female 192

LVEF

≤ 0.25 831

> 0.25 401

NYHA Class

≤ II 861

> II 351

QRS

< 0.12 s 597

0.12 - 0.15 s 352

> 0.15 s 262

Beta-blockers

Yes 844

No 388

Variable Number of patients

Figure C-5. Hazard ratios and 95 percent conﬁdence intervals

Analysis of Inducibility as a Risk Factor

There were 583 patients enrolled in MADIT II who had EP testing performed

either prior to or during ICD implant. The deﬁnition for inducibility was the

same one used for the MADIT I study. Of these 583 patients, 373 (63 percent)

were not inducible and the remaining 210 (36 percent) were inducible. Of the

210 patients who were inducible, 180 (88 percent) had EP testing performed

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CLINICAL STUDY - MADIT II C-21

at implant using a catheter method and 24 (12 percent) using the ICD for

induction; there was no data on the method of induction for 6 patients.

The Occurrence of ICD Therapy for VT, VF, or VT/VF Combined

Therapy for VT was deﬁned as antitachycardia pacing (ATP) or ICD shock

delivered by the device in an attempt to stop an arrhythmia as reported by the

enrolling center. Therapy for VF was deﬁned as the delivery of ICD shock

therapy. The endpoint for VT/VF was deﬁned by the occurrence of either VT or

VF therapy. The occurrence of therapy for each of these groups is provided in

Table C-12 on page C-21. All analyses were Cox regression analyses, stratiﬁed

by enrollment center, with time to VT, time to VF or time to VT/VF therapy

as the respective endpoint.

Table C-12. ICD patients receiving one or more therapies

Type of ICD TherapyaNumber of Patients Percent of Patients with

Therapy Episodes

VT (ATP or shock) 89 15.4%

VF (Shock only) 36 6.2%

VT/VF VF (ATP + shock) 114 19.7%

a. Some patients received both types of therapy.

Predictions of VT and VF Therapy in ICD Patients

A statistical analysis was performed to evaluate whether inducibility at EP

testing provides predictability of the potential effectiveness of an ICD. To this

end, the occurrence of each of the three endpoints deﬁned above (VT, VF

and VT/VF), in ICD patients with EP testing were evaluated. Analyses were

done by Cox proportional hazards regression, stratiﬁed by enrollment center.

(Table C-13 on page C-22)

A list of potential risk factors was considered for these endpoints, such as age,

gender, and standard cardiological variables like NYHA class, EF, etc., and

developed a parsimonious regression model in the 583 ICD patients identiﬁed

above. GENDER and BUN (dichotomized at up to 25 versus 26 and over) were

observed as potential risk factors for these endpoints, with males and elevated

BUN associated with increased occurrence of these endpoints. Further

analysis investigated whether inducibility added any additional, independent

predictive power for each of these endpoints.

The conclusion was that inducibility increases the risk of VT events by perhaps

60 percent (p=0.07) and decreases the risk of VF events by perhaps 50

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C-22 CLINICAL STUDY - MADIT II

percent (p=0.08). As a consequence of these opposite directional effects of

similar magnitudes, there was no reliable evidence that inducibility affects the

frequency of VT/VF events (p=0.26); it may be associated with a slight increase

since VT events occur more frequently than VF.

Table C-13. Therapy predictability based on induced arrhythmia

Inducible

Therapy Delivered for the

Following Type of Arrhythmia Yes No

Yes 729

No 202 341

Yes 43 46

No 166 324

VT/VF

Yes 48 66

No 161 304

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D-1

CLINICAL STUDY - VENTAK AV II DR

APPENDIX D

CLINICAL STUDY POPULATIONS

Guidant ICDs have been demonstrated to be safe and effective in patient

populations including, but not limited to, those with:

• Prior myocardial infarction and an ejection fraction (EF) ≤30%, based on

the Guidant sponsored MADIT II clinical study. (Guidant devices were the

only devices studied in the MADIT II clinical trial. The trial demonstrated

these devices to be safe and effective in the MADIT II population.)

• Prior myocardial infarction, left ventricular ejection fraction of ≤35%, and

a documented episode of nonsustained VT, with an inducible ventricular

tachyarrhythmia, based on the Guidant sponsored MADIT clinical study.

(Guidant devices were the only devices studied in the MADIT clinical trial.

The trial demonstrated these devices to be safe and effective in the MADIT

population.)

CHRONIC IMPLANT STUDY - VENTAK AV II DR

Since this pulse generator system has many of the same therapies, diagnostics,

and electrophysiology testing features as the VENTAK AV III DR system, the

VENTAK AV II DR implant study, which was used to support the VENTAK AV III

DR system, was used also to support this pulse generator system.

The purpose of the implant study was to conﬁrm that the VENTAK AV II DR

could sense, detect, and deliver ventricular tachyarrhythmia therapy. In

addition, the adaptive-rate pacing function was evaluated by exercise testing.

Fifty-two patients were enrolled and implanted in 18 centers outside the U.S.

between June 27 and October 21, 1997. A total of 53 devices were used

throughout the duration of the study and consisted of VENTAK AV II DR,

models 1821 and 1826. The VENTAK AV II was approved for commercial

distribution in the U.S. on March 13, 1998.

This clinical data remains applicable to these pulse generator systems since

there are no signiﬁcant differences between tachyarrhythmia therapy and

adaptive-rate pacing capabilities.

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D-2 CLINICAL STUDY - VENTAK AV II DR

Patients Studied

The patients (46 M/ 6 F) had a mean age of 60 years (range 30 to 78) and a left

ventricular ejection fraction of 36% (14% to 76%). Most (86%) presented with

coronary artery disease or ischemic cardiomyopathy and 53% presented with

monomorphic ventricular tachycardia (MVT) as their primary arrhythmia.

Methods

This was an observational study. No control group was used. Patients

underwent standard ICD implant procedure and were evaluated at

predischarge, 1 month, and 3 months postimplant. At the one-month follow-up,

an exercise test consisting of a 6 minute brisk walk or 6 minutes of stair climbing

was required for all patients included in the study if the accelerometer sensor

was programmed on. The purpose of the exercise test was to verify if there

was an adequate rate response of the sensor under exercise conditions. After

the test, the device was interrogated to verify if the rate response during activity

functioned according to patient need. If the rate response was insufﬁcient, the

trending function was used to optimize the sensor settings.

Results

The mean implant duration was 3.03 months (range 0.23 to 3.8) with a

cumulative implant duration of 157.4 months. All patients were implanted in a

lead alone conﬁguration. Two patients were later revised to add SQ arrays. The

mean DFT for 26 patients who were tested under a step down to failure protocol

was 10.3 J stored energy. A total of 432 episodes of ventricular arrhythmias

(VF/PVT and MVT) were treated including spontaneous (N = 112) and induced

(N = 320). Three patients had episodes that were not converted by the device.

One patient had 4 VF episodes during DFT testing at implant that were not

converted by the device and were converted externally. A second patient

had an electrical storm directly postimplant in which two episodes of MVT

were converted externally; the device detected all episodes appropriately and

used multiple attempts to deliver therapy for all episodes in the storm. A third

patient’s MVT accelerated to VF and was successfully terminated by the device.

All other episodes of ventricular arrhythmias were converted by device therapy.

There were two patient deaths: one was classiﬁed witnessed, noncardiac,

nonsudden, and the other was classiﬁed unwitnessed, assumed sudden.

Forty patients had the sensor programmed “ON” and performed an exercise

test. The remaining patients were not tested for the following reasons: patient

had sinus rhythm and did not require adaptive-rate pacing, patient could not

tolerate exercise testing, and patient death. Nominal settings were appropriate

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CLINICAL STUDY - VENTAK AV II DR D-3

for 80% of patients tested; in all cases, the physician was able to program

appropriate adaptive-rate settings to accommodate patient need (Table D-1

on page D-3).

Table D-1. Implant study results

Effectiveness Measure VENTAK AV II DR

Mean + SD [95% CI]

Deﬁbrillation threshold (J) stored energy 10.3 + 3.7

[8.8, 11.8]

N=26

Safety Measure Rate (%)

Operative mortality 1/52 (1.9%)

Conversion efﬁcacy for all ventricular arrhythmias 425/432 (98.4%)

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D-4 CLINICAL STUDY - VENTAK AV II DR

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E-1

CLINICAL STUDY - VITALITY

APPENDIX E